Active Ingredients (In Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate (NDC 55629-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each capsule), purpose:, uses:, warnings:, do not use, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Pain reliever/ fever reducer
Cough suppressant
Antihistamine
temporarily relieves common cold/flu symptoms:
Liver warning This product contains acetaminophen. Severe liver damage may occur if you take:
Sore throat warning If sore throat is severe, lasts more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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, and tranquilizers may increase drowsiness
| Adults and children 12 years of age and older | 2 LiquiCaps with water every 4 hours |
| Children under 12 years of age | ask doctor |
When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing.
polyethylene glycol 400, propylene glycol, povidone k30, fd&c blue no. 1, d&c yellow no. 10, titanium dioxide, gelatin, glycerin, sorbitol, water
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 15 mg, Doxylamine Succinate 6.25 mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-014-
EXP DATE:
WARNING:
KEEP OUT OF REACH OF CHILDREN
STORE CONTROLLED ROOM TEMPERATURE OF 59° - 86°F (15° - 30°C)
PROTECT FROM LIGHT, MOISTURE AND FREEZING
THIS IS A BULK SHIPMENT INTENDED FOR FURTHER PROCESSING ONLY.
CONTENTS SHOULD BE APPROVED, REPACKAGED IMMEDIATELY AND LABELED IN STRICT CONFORMANCE WITH
THE F.D & C.ACT AND REGULATIONS THEREUNDER.
* Please review the disclaimer below.