Available Formats

• Active ingredient (in each 5 mL)

  Acetaminophen 160 mg

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• Purpose

  Pain reliever/fever reducer

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• Uses

  temporarily:

  • reduces fever

  • relieves minor aches and pains due to:

  • the common cold

  • flu

  • headache

  • sore throat

  • toothache

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• Warnings

  Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes

  • more than 5 doses in 24 hours, which is the maximum daily amount

  • with other drugs containing acetaminophen

  Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening

  • blisters

  • rash

  If a skin 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.

  Do not use

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

  • if your child has ever had an allergic reaction to this product or any of its ingredients

  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

  • new symptoms occur

  • redness or swelling is present

  These could be signs of a serious condition.

  Keep out of reach of children.

  Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

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• Directions

  • this product does not contain directions or complete warnings for adult use

  • do not give more than directed (see overdose warning)

  • shake well before using

  • mL = milliliter

  • find right dose on chart. If possible, use weight to dose; otherwise, use age.

  • push air out of syringe. Insert syringe tip into bottle opening.

  • flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.

  • pull yellow part of syringe until it reaches and stays at the correct dose

  • dispense liquid slowly into child’s mouth, toward inner cheek

  • repeat dose every 4 hours while symptoms last

  • do not give more than 5 times in 24 hours

  • replace cap tightly to maintain child resistance

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

  * or as directed by a doctor

  Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

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• Other information

  • store at 20-25°C (68-77°F)

  • do not use if printed neckband is broken or missing

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• Inactive ingredients

  anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

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• Questions or comments?

  1-800-632-6900

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• Package/Label Principal Display Panel

  COMPARE TO the active ingredient of INFANTS’ TYLENOL® ORAL SUSPENSION

  See side panel

  SEE NEW WARNINGS

  FOR AGES 2-3 YEARS

  Infants’

  Pain & Fever

  Acetaminophen 160 mg per 5 mL

  Pain Reliever/Fever Reducer

  Suspension Liquid

  DYE-FREE

  Non-Staining

  Use only with enclosed syringe.

  See side panel for more information.

  Pediatrician Preferred Dosing System

  Alcohol Free

  Aspirin Free

  Ibuprofen Free

  No High Fructose Corn Syrup

  Grape Flavor

  2 FL OZ 59 mL)

  

  

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• INGREDIENTS AND APPEARANCE

  INFANTS PAIN AND FEVER  acetaminophen suspension

  Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-766 Route of Administration ORAL

  Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg  in 5 mL

  Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)   CALCIUM SULFATE (UNII: WAT0DDB505)   CARRAGEENAN (UNII: 5C69YCD2YJ)   GLYCERIN (UNII: PDC6A3C0OX)   CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)   CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)   PROPYLENE GLYCOL (UNII: 6DC9Q167V3)   PROPYLPARABEN (UNII: Z8IX2SC1OH)   WATER (UNII: 059QF0KO0R)   SODIUM BENZOATE (UNII: OJ245FE5EU)   SORBITOL (UNII: 506T60A25R)   SUCRALOSE (UNII: 96K6UQ3ZD4)   SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X)

  Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-766-16 1 in 1 CARTON 03/15/2012 1 59 mL in 1 BOTTLE; Type 0: Not a Combination Product

  Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/15/2012

  Labeler - Kroger Company (006999528)

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