Quick answers
- What is Acetaminophen, doxylamine and phenylephrine used for?
- The Drug Facts label of NightTime Sinus (Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.) lists these uses: temporarily relieves nasal and sinus symptoms: sinus pain headache nasal and sinus congestion runny nose and sneezing.
- Do I need a prescription for Acetaminophen, doxylamine and phenylephrine?
- 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, doxylamine and phenylephrine 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.
NightTime Sinus · Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Acetaminophen 325 mg · Doxylamine succinate 6.25 mg · Phenylephrine hydrochloride 5 mg, capsule, liquid filled (oral)
Active ingredient (in each softgel)
Acetaminophen 325 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg
Purpose
Pain reliever Antihistamine Nasal decongestant
Uses
temporarily relieves nasal and sinus symptoms: sinus pain headache nasal and sinus congestion runny nose and sneezing
Warnings
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen 3 or more alcoholic drinks daily 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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product. to make a child sleep
Ask a doctor before use if
you have liver disease heart disease thyroid disease diabetes high blood pressure glaucoma a breathing problem such as emphysema or chronic bronchitis trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if
you are taking sedatives or tranquilizers taking the blood thinning drug warfarin
When using this product
do not use more than directed excitability may occur, especially in children marked drowsiness may occur avoid alcoholic drinks be careful when driving a motor vehicle or operating machinery alcohol, sedatives & tranquilizers may increase drowsiness
Stop use and ask a doctor if
redness or swelling is present you get nervous, dizzy or sleepless fever gets worse or lasts more than 3 days new symptoms occur symptoms do not get better within 7 days or are accompanied by a fever
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children
Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and children even if you do not notice any signs or symptoms.
Directions
take only as directed - see Overdose warning do not exceed 4 doses per 24 hrs
| adults and children 12 years of age and over | take 2 softgels with water every 4 hrs |
| Children 4 to under 12 years of age | ask a doctor |
| children under 4 years of age | do not use |
when using other Daytime or Nighttime products, carefully read each label to insure correct dosing
Inactive ingredients
FD&C Blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. Wuhan, Hubei 430206, China
— FDA label of NightTime Sinus, Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd., effective November 25, 2024. 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 325 mg · Doxylamine succinate 6.25 mg · Phenylephrine hydrochloride 5 mg · capsule, liquid filled (oral) · 2 products
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.
- Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.1 product
- Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.1 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.