Quick answers
- What is Acetaminophen and caffeine used for?
- The Drug Facts label of Excedrin Tension Headache (Haleon US Holdings LLC) lists these uses: temporarily relieves minor aches and pain due to; headache; muscular aches.
- Do I need a prescription for Acetaminophen and caffeine?
- No. The products on this page are sold without a prescription (over the counter).
- Is a store brand the same as the name brand?
- Products listed together below have the same active ingredients, in the same amount and the same form, as registered with the FDA. Inactive ingredients (such as colors, flavors and fillers) and package sizes can differ. Compare the “Active ingredient” box on both packages, and ask a pharmacist if you are not sure.
- Has Acetaminophen and caffeine been recalled?
- No recall linked to these products appears in the FDA enforcement reports we use.
Drug Facts label
Every over-the-counter medicine must carry a “Drug Facts” box in the same order, set by FDA rules. Below is the label of one product for each common strength and form, quoted word for word. Your own package can differ (for example, children’s products have other directions): always follow the label on your package.
Excedrin Tension Headache · Haleon US Holdings LLC
Acetaminophen 500 mg · Caffeine 65 mg, tablet, film coated (oral)
Active ingredient (in each caplet)
Acetaminophen 500 mg Caffeine 65 mg
Purpose
Pain reliever Pain reliever aid
Uses
- temporarily relieves minor aches and pain due to:
- headache
- muscular aches
Warnings
- Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Do not use
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
Ask a doctor or pharmacist before use if
you are
- taking the blood thinning drug warfarin
Stop use and ask a doctor if
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days These could be signs of a serious condition.
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat.
Directions
- do not use more than directed
- adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours
- children under 12 years: ask a doctor
Inactive ingredients
benzoic acid, D&C red no. 27 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C yellow no. 6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide
Questions?
1-800-468-7746
— FDA label of Excedrin Tension Headache, Haleon US Holdings LLC, effective March 13, 2024. See the official label on DailyMed →
Tension Headache Relief · Nuvicare LLC
Acetaminophen 500 mg · Caffeine 65 mg, tablet (oral)
Active ingredient (in each caplet)
Acetaminophen 500mg Caffeine 65 mg
Purpose
Acetaminophen 500mg................................Pain reliever Caffeine 65mg............................................Pain reliever aid
Uses
temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
ALLERGY ALERT: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- no more than 6 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heartbeat. DO NOT USE:
- if you have ever had an allergic reaction to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
- you have liver disease
Ask a doctor or pharmacist before use if
you are
- taking the blood thinning drug warfarin Stop use and ask doctor if
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days. These could be signs of a serious condition.
If pregnant or breast-feeding
ask a health professional before use. KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Do not use more than directed adults and children 12 years and over: take 2 caplets every 6 hours; not more than 6 caplets in 24 hours chlidren under 12 years: ask a doctor
Other information
- store at 20°-25°C (68°-77°F)
- close cap tightly after use
- read all product information before using.
Inactive ingredients
Colloidal Silicon Dioxide, Croscarmellose Sodium, D & C Red # 27, F D & C yellow # 6, F D & C Blue # 2, Microcrystalline Cellulose, Magnesium Stearate, Polyethylene Glycol, Polyvinyl Pyrrolidone, Pregelatinized Starch, Polyvinyl Alcohol, Stearic Acid Powder, Titanium Dioxide, Talc.
Questions?
Call 1 (718) 337-8733 or visit support@nuvicare.com
— FDA label of Tension Headache Relief, Nuvicare LLC, effective December 19, 2025. See the official label on DailyMed →
Sed-Max · Command Brands, LLC
Acetaminophen 500 mg · Caffeine 65 mg, tablet, coated (oral)
Active ingredient (s)
Acetaminophen 500mg Caffeine 65mg
Purpose
Pain reliever/fever reducer Pain reliever aid
Uses
temporary relief of minor aches and pains due to:
- headache
- muscular aches
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you
- take more than 8 caplets in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
- Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.
Do not use
- if you are allergic to acetaminophen
- with other products containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
you have liver disease
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
- any new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days These could be signs of a serious skin condition Pregnancy/Breastfeeding
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
- do not use more than directed
- Adults and children 12 years and over: take 2 caplets every 6 hours. Do not take more than 8 caplets in 24 hours
- Children under 12 years of age: ask a doctor
Inactive ingredients
corn starch, croscarmellose, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
— FDA label of Sed-Max, Command Brands, LLC, effective January 19, 2017. See the official label on DailyMed →
Tension Headache Relief · Allegiant Health
Acetaminophen 500 mg · Caffeine 65 mg, capsule, coated (oral)
Active ingredient (s)
Acetaminophen 500 mg Caffeine 65mg
Purpose
Pain reliever Pain reliever aid
Uses
(s) temporarily relieves minor aches and pains due to: headache muscular aches
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you
- take more than 8 tablets in 24 hours, which is the maximum daily amount
- take with other drugs containing acetaminophen
- have 3 or more alcoholic drinks every day while using this product Allergy alert : Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
- Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat.
Do not use
if you are allergic to acetaminophen with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
you have liver disease
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin
Stop use and ask a doctor if
any new symptoms occur painful area is red or swollen pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days These could be signs of a serious condition. Pregnancy/Breastfeeding
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
Directions
Do not use more than directed Adults and children 12 years and over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours Children under 12 years: ask a doctor
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
Questions?
1-888-952-0050 (Monday through Friday 9AM - 5PM EST
— FDA label of Tension Headache Relief, Allegiant Health, effective November 22, 2021. See the official label on DailyMed →
Tension Headache Relief · Allegiant Health
Acetaminophen 500 mg · Caffeine 65 mg, capsule (oral)
Active ingredient (in each caplet)
Acetaminophen 500 mg Caffeine 65mg
Purpose
Pain reliever Pain reliever aid
Uses
temporary relief of minor aches and pains due to
- headache
- muscular aches
Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if you
- take more than 8 tablets in 24 hours, which is the maximum daily amount
- take with other drugs containing acetaminophen
- have 3 or more alcoholic drinks every day while using this product
- Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash If a skin reaction occurs, stop use and seek medical help right away.
- Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. Do Not Use
- with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure. Ask doctor before use if you have liver disease Stop Use and ask a doctor if
- any new symptoms occur
- symptoms do not get better or worsen
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of accidental overdose, get medical help or contact a PoisonControlCenter immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
Do not exceed recommended dosage. Adults and children 12 years and over : take 2 tablets every 6 hours. Do not take more than 8 tablets in 24 hours Children under 12 years: ask a doctor
Inactive ingredients
corn starch, croscarmellose sodium, crospovidone, D&C red #27 aluminum lake, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide
— FDA label of Tension Headache Relief, Allegiant Health, effective November 16, 2017. See the official label on DailyMed →
BackAid · Kobayashi Healthcare International, Inc.
Acetaminophen 500 mg · Caffeine 75 mg, tablet, film coated (oral)
Active ingredient (in each caplet)
Acetaminophen, 500 mg Caffeine, 75 mg
Purpose
Analgesic (pain reliever) Analgesic aid
Uses
For the temporary relief of minor aches and pains associated with backache muscular aches headache
Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 6 caplets in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product. Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.
Do not use
with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if
you have liver disease.
Ask a doctor or pharmacist before use if
you are taking the blood thinning drug warfarin.
When using this product
limit the use of caffeine-containing medications, foods or beverages because too mush caffeine may cause nervousness irritability sleeplessness occasional rapid heartbeat The recommended dose of this product contains about as much caffeine as one and one-half cups of coffee.
Stop use and ask a doctor if
pain gets worse or lasts more than 10 days fever gets worse or lasts more than 3 days redness or swelling is present any new symptoms appear
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
In case of overdose, get medical help or contact a poison control center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
Read all package directions and warnings before use. Use only as directed. Adults: Two (2) caplets with a full glass of water every 6 hours while symptoms persist, not to exceed 3 doses (6 caplets) in 24 hours, or as directed by a doctor. Do not exceed recommended dosage. For use by normally healthy adults only. Persons under 18 years of age should use only as directed by a doctor.
Inactive ingredients
Corn starch, croscarmellose sodium, hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, povidone, silicon dioxide, stearic acid, talc, titanium dioxide, triglycerides.
Questions?
1-800-792-2582.
— FDA label of BackAid, Kobayashi Healthcare International, Inc., effective October 21, 2025. See the official label on DailyMed →
This page is not medical advice. Read the label on your package, and ask a pharmacist or doctor if you are not sure a medicine is right for you, for your child, or with your other medicines.
Same medicine, other brands
Each group lists the products that have exactly the same active ingredients, in the same amount and form, as registered with the FDA (NDC Directory). A store brand in the same group has the same medicine as the name brand; inactive ingredients, flavors and package sizes can differ. Each product links to its own official label.
Acetaminophen 500 mg · Caffeine 65 mg · tablet, film coated (oral) · 13 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Cafizetamol Forte | Opmx LLC | DailyMed |
| Doloneuro-Tropas | Opmx LLC | — |
| DRX CHOICE Tension Headache | Raritan Pharmaceuticals Inc. | DailyMed |
| Excedrin Tension Headache | Haleon US Holdings LLC | DailyMed |
| KORTRIBION Pain Reliever | Opmx LLC | — |
| Mejoral | Opmx LLC | DailyMed |
| Migrafein FORTE | Opmx LLC | DailyMed |
| Neo-Lubrina Fuerte | Opmx LLC | DailyMed |
| PANADOL Extra | Haleon US Holdings LLC | DailyMed |
| Tension Headache | Cardinal Health 110, LLC. DBA Leader | DailyMed |
| Tension Headache Aspirin Free | CVS Pharmacy | — |
| Tension Headache Aspirin-Free | Rite Aid Corporation | DailyMed |
| Tension Headache Relief | HHH Pharmaceuticals | — |
Acetaminophen 500 mg · Caffeine 65 mg · tablet (oral) · 8 products
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| DoloDent Toothache For adults | Pharmadel LLC | DailyMed |
| NOTTS - Tension Headache | Vivunt Pharma LLC | DailyMed |
| Tension Headache Pain Relieving Aid | Wal-Mart Stores Inc | DailyMed |
| Tension Headache Relief | Hi-Tech Nutraceuticals, LLC | DailyMed |
| Tension Headache Relief | Nuvicare LLC | DailyMed |
| Tension Headache Relief | Pioneer Life Sciences, LLC | — |
| Tension Headache Relief | Time Cap Labs Inc | DailyMed |
| Tension Headache Relief | Walgreens | DailyMed |
Acetaminophen 500 mg · Caffeine 65 mg · tablet, coated (oral) · 3 products
Acetaminophen 500 mg · Caffeine 65 mg · capsule, coated (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Tension Headache Relief | Allegiant Health | DailyMed |
Acetaminophen 500 mg · Caffeine 65 mg · capsule (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| Tension Headache Relief | Allegiant Health | DailyMed |
Acetaminophen 500 mg · Caffeine 75 mg · tablet, film coated (oral) · 1 product
Drug Facts for this strength and form ↑
| Brand or product name | Company on the label | Label |
|---|---|---|
| BackAid | Kobayashi Healthcare International, Inc. | DailyMed |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| acetaminophen 500 mg · caffeine 65 mg tablet, film coated | Generic | $0.0604 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that sell this medicine
The company named on the package (maker or distributor), as listed in the FDA NDC Directory, with its number of over-the-counter products of this medicine.
- Opmx LLC6 products
- Haleon US Holdings LLC2 products
- Allegiant Health2 products
- Time Cap Labs Inc1 product
- Vivunt Pharma LLC1 product
- CVS Pharmacy1 product
- Walgreen Company1 product
- Raritan Pharmaceuticals Inc.1 product
- Walgreens1 product
- Cardinal Health 110, LLC. DBA Leader1 product
- Rite Aid Corporation1 product
- Command Brands, LLC1 product
- Pioneer Life Sciences, LLC1 product
- Wal-Mart Stores Inc1 product
- Hi-Tech Nutraceuticals, LLC1 product
- Nuvicare LLC1 product
- Kobayashi Healthcare International, Inc.1 product
- Pharmadel LLC1 product
- HHH Pharmaceuticals1 product
- Target Corporation1 product
Recalls
No recall linked to these products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- FDA rule for the Drug Facts label (21 CFR 201.66)
Only medicines marketed under FDA rules for nonprescription drugs (an FDA monograph or an FDA approval) are listed. Homeopathic products are not listed: the FDA does not evaluate them for safety or effectiveness.