MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled
FAMILY DOLLAR
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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Active ingredients (in each SOFTGEL)
Acetaminophen 325 mg
Dextromethorphan hydrobromide 10 mg
Doxylamine Succinate 6.25 mg
Phenylephrine hydrochloride 5 mg
Inactive ingredients FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac,sorbitol sorbitan solution, titanium dioxide
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· sore throat · nasal and sinus congestion
· temporarily reduces fever
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 softgels with water
every 4 hours. Do not exceed 10 capsules in 24 hours or as directed by a doctor.
· children under 12 years: do not use
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away(1 800-222-1222. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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.
MAXIMUM STRENTH NIGHT COLD AND FLU FORMULA
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl capsule, liquid filled |
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Labeler - FAMILY DOLLAR (024472631) |
Registrant - TIME CAP LABORATORIES, INC. (037052099) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
MARKSANS PHARMA LTD | 925822975 | manufacture(55319-934) |