Active Ingredients (In Each Capsule)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by One2zee Limited Liability Company for the product Acetaminophen, Guaifenesin, Dextromethorphan Hbr, Phenylephrine Hcl (NDC 55629-015). 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, stop use and ask a doctor if, overdose warning:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine Hydrochloride 5 mg
Pain reliever/ fever reducer
Cough suppressant
Expectorant
Nasal decongestant
ο nasal congestion
ο sinus congestion & pressure
ο cough due to minor throat & bronchial irritation
ο minor aches & pains
ο headache
ο fever
ο sore throat
Liver warning
This product contains acetaminophen. Severe liver damage may occur if you take
more than 4 softgels in 24 hours, which is the maximum daily amount for this product
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product
Sore throat warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
These could be signs of a serious condition.
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 as well as for children even if you do not notice any signs or symptoms.
| adults & children 12 years of age and over | 2 softgels with water every 4 hours |
| Children under 12 years of age | ask a 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 yellow no. 6, titanium dioxide, gelatin, glycerin, sorbitol, water
Acetaminophen, Dextromethorphan HBr, Guifenesin, Phenylephrine HCL capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Guifenesin 200mg, Phenylephrine Hydrochloride USP 5mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-015-
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.