Concentrated aspirin freeinfants suspension/ drops

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 childs 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 24

under 2 years

ask a doctor

24-35

23 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 20-25C (68-77F)
  • 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?

1-888-SAFEWAY

Ingredients and appearance - Product information

Concentrated aspirin freeinfants suspension/ drops- Acetaminophen

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 21130-289
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 80 mgin 0.8 mL

Inactive Ingredients

Ingredient Name Code
Anhydrous citric acid ( UNII: XF417D3PSL)
Butylparaben ( UNII: 3QPI1U3FV8)
Carboxymethylcellulose sodium ( UNII: K679OBS311)
Carrageenan ( UNII: 5C69YCD2YJ)
D&c red no. 33 ( UNII: 9DBA0SBB0L)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Glycerin ( UNII: PDC6A3C0OX)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Cellulose, microcrystalline ( UNII: OP1R32D61U)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Sodium benzoate ( UNII: OJ245FE5EU)
Sorbitol ( UNII: 506T60A25R)

Product Characteristics

Color PURPLE Flavor GRAPE

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph not final part343 USA

Labeler - Safeway( 009137209)

Principal display panel

Compare to Concentrated Tylenol® Infants Drops active ingredient

Infants Drops

For Ages 2 to 3

Concentrated

Aspirin Free

Suspension Drops

Acetaminophen

Fever Reducer

Pain Reliever

Alcohol Free

Use only with enclosed dropper

Grape Flavor

See New Warnings Information

80 mg per 0.8 mL

Suspension Drops Carton