ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE- acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate capsule, liquid filled
ONE2ZEE LIMITED LIABILITY COMPANY
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine Hydrochloride 5 mg
Doxylamine Succinate 6.25 mg
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
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.
Do not use to sedate children.
These could be signs of a serious condition.
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, sodium hydroxide, FD&C blue #1, D&C yellow #10, titanium dioxide, gelatin, glycerin, sorbitol, water
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCL, Doxylamine Succinate capsules
Each Softgel Contains:
(Acetaminophen USP 325 mg, Dextromethorphan Hydrobromide USP 10 mg, Phenylephrine Hydrochloride USP 5mg, Doxylamine Succinate 6.25 mg)
LOT NO:
DRUM NO:
MFG DATE:
QUANTITY:
NDC NO: 55629-016-
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.
ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, DOXYLAMINE SUCCINATE
acetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate capsule, liquid filled |
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Labeler - ONE2ZEE LIMITED LIABILITY COMPANY (078656111) |
Registrant - ONE2ZEE LIMITED LIABILITY COMPANY (078656111) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Medgel Private Limited | 677385498 | manufacture(55629-016) |