Kirkland Signature infants pain relief

Dosage form: suspension/ drops
Ingredients: ACETAMINOPHEN 80mg in 0.8mL
Labeler: Costco Wholesale Company
NDC Code: 63981-289

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.

Costco Wholesale Corp. Infants' Pain Relief Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
  • the common cold
  • flu
  • headache
  • sore throat
  • toothache

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

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.

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

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.

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.

Directions
  • do not give more than directed (see Liver warning)
  • shake well before using
  • find right dose on chart. If possible, use weight to dose; otherwise use age.
  • use only enclosed dropper designed for use with this product. Do not use any other dosing device.
  • fill to dose level
  • dispense liquid slowly into child’s mouth, toward inner cheek
  • if needed, repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
  • do not give for more than 5 days unless directed by a doctor
  • replace dropper tightly to maintain child resistance
  • this product does not contain directions or complete warnings for adult use
Dosing Chart
Weight(lb) Age(yr)Dose (mL)
under 24under 2 years ask a doctor
24-352–3 years 1.6 mL (0.8 + 0.8 mL)

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

Other information
  • store at 20°-25°C (68°-77°F)
  • do not use if printed bottle wrap is broken or missing

Inactive ingredients

anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, carrageenan, D&C red no. 33, FD&C blue no. 1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol solution

Questions or comments?

1-800-774-2678

Principal Display Panel

COMPARE TO CONCENTRATED TYLENOL® INFANTS' DROPS active ingredient

INFANTS'

Pain Relief

Acetaminophen

Concentrated Drops

Fever Reducer

Pain Reliever

Aspirin Free

Ibuprofen Free

Alcohol Free

Use only with enclosed dropper

See New Warnings Information

Ages 2-3

Grape Flavor

80 mg per 0.8 mL

Infants' Pain Relief Carton Image 1

Infants' Pain Relief Carton Image 2

KIRKLAND SIGNATURE INFANTS PAIN RELIEF 
acetaminophen suspension/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63981-289
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN80 mg  in 0.8 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
BUTYLPARABEN 
CARBOXYMETHYLCELLULOSE SODIUM 
CARRAGEENAN 
D&C RED NO. 33 
FD&C BLUE NO. 1 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
CELLULOSE, MICROCRYSTALLINE 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SORBITOL 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63981-289-162 BOTTLE, DROPPER (BOTTLE) in 1 CARTON
130 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/11/1998
Labeler - Costco Wholesale Company (103391843)

Revised: 11/2011
 
Costco Wholesale Company

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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