Label: ONLY FOR COLD AND FLU COUGH SUPPRESSANT- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 28, 2019

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  • DRUG FACTS
  • Active ingredient (in each caplet)
    Acetaminophen 325 mg - Dextromethorphan HBr 10 mg - Guaifenesin 200 mg - Phenylephrine HCl 5 mg
  • Purpose
    Pain reliever/Fever reducer - Cough suppressant - Expectorant - Nasal decongestant
  • Uses:
    • temporarily relieves:      • minor aches & pains associated with a cold, the flu or a sore throat • headache • cough due to minor throat & bronchial irritation • nasal congestion • sinus ...
  • Warnings:
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: • with other drugs containing acetaminophen - • more than 8 caplets in 24 hrs, which is the maximum ...
  • Directions:
    Do not take more than directed - See Overdose warning - take with a full glass of water • do not exceed 8 caplets per 24 hours -  adults and children 12 yrs of age & over2 caplets with ...
  • Other Information:
    • Store at room temperature between 20-25°C (68-77°F). • Avoid excessive heat and humidity
  • Inactive Ingredients:
    colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate, FD&C yellow #6, gelatin, magnesium stearate, maltodextrin, mica, microcrystalline cellulose, polyethylene glycol ...
  • Questions Or Comments ?
    1-833-665-9444.
  • SPL UNCLASSIFIED SECTION
    NDC: 73006-108-41 - READ AND KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION. Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX ...
  • Packaging
    image description
  • INGREDIENTS AND APPEARANCE
    Product Information