Infants Pain Relief Dye-free
FDA Label NDC 67091-121

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Infants Pain Relief Dye-free (NDC 67091-121). 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 ingredient (in each 5 ml), purpose, uses, warnings, do not use, ask a doctor before use if your child has, ask a doctor or pharmacist before use if your child is, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml)

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

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 acetaminophen
  • Sore throat warning: if sore throat is severe, persists for more than 2 days, or is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do Not Use

  • with any other drug containing acetaminophen (prescription or non prescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.
  • if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin

When Using This Product

do not exceed recommended dose (see overdose warning)

Stop Use And Ask A Doctor If

  • pain gets worse or lasts more than 5 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • These could be signs of a serious condition.

Keep Out Of Reach Of Children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.

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 syringe
  • find right dose on chart below
  • remove cap and insert syringe, invert the bottle and draw the liquid to the prescripbed level.
  • dispense liquid slowly into childs mouth towards inner cheek
  • repeat dose every 4 hours if needed
  • do not give more than 5 times in 24 hours
  • replace the cap tightly to maintain child resistance
  • return dispenser to the box after thorough cleaning

    • Weight (lb) Age (yr) Dose (mL)* 
     under 24 under 2 years ask a doctor
     24-35 lbs 2-3 years 5 mL

    * or as directed by a doctor

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 gum

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 Free

For Ages 2-3 Years

Dye-Free

Cherry Flavor

2 FL OZ (60 mL) 160 mg per 5 mL

Box (Wc5742oz)

Box (Wc5742oz)

* Please review the disclaimer below.