Label: INFANTS PAIN RELIEF DYE-FREE- acteaminophen suspension

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 9, 2019

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  • Active ingredient (in each 5 mL)
    Acetaminophen 160 mg
  • Purpose
    Pain reliever/fever reducer
  • KEEP OUT OF REACH OF CHILDREN
  • Uses
    temporarily reduces fever - relieves minor aches and pains due to: the common cold - sore throat - flu - toothache - headache
  • Warnings
    Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes: more than 5 doses in 24 hours, which is maximum daily amount - with other drugs containing ...
  • Directions
    this product does not contain directions or complete warnings for adult dose - do not give more than directed (see overdose warning) shake well before use - use only enclosed dosing ...
  • Other information
    store between 20-25oC(68-77oF)
  • Inactive ingredients
    citric acid anhydrous, butyl paraben, flavor, glycerin, maltitol, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propyl paraben, purified water, sucralose, xanthan ...
  • PDP
    *Compare to the active ingredient in Childrens TYLENOL®Suspension - Infants Oral Suspension Pain relief - ACETAMINOPHEN 160 mg per 5 mL - PAIN RELIEVER-FEVER REDUCER - Alcohol Free - Aspirin & Ibuprofen ...
  • INGREDIENTS AND APPEARANCE
    Product Information