EQUALINE PAIN RELIEF INFANTS- acetaminophen suspension/ drops 
Supervalu Inc

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.

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SuperValu Pain Relief Infants' Drops Drug Facts

Active ingredient (in each 0.8 mL)

Acetaminophen 80 mg

Purpose

Fever reducer/pain reliever

Uses

temporarily:

Warnings

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

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

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

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?

1-877-932-7948

Principal Display Panel

Compare to Concentrated Tylenol® Infants’ Drops active ingredient

For Ages 2 to 3

Concentrated

Pain Relief

Infants' Drops

Acetaminophen

Fever Reducer

Pain Reliever

Alcohol Free

Aspirin Free

Ibuprofen Free

Use only with enclosed dropper

See New Warnings Information

Grape Flavor

80 mg per 0.8 mL

Pain Relief Infants' Drops Carton

Pain Relief Infants' Drops Carton

EQUALINE PAIN RELIEF  INFANTS
acetaminophen suspension/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:41163-289
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg  in 0.8 mL
Product Characteristics
Color PURPLE Score     
Shape Size
Flavor GRAPE Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:41163-289-05 1 in 1 CARTON
1 15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/30/2004
Labeler - Supervalu Inc (006961411)

Revised: 6/2009
Document Id: bef5c9b8-f636-4b10-9ef6-0467128f6874
Set id: bef5c9b8-f636-4b10-9ef6-0467128f6874
Version: 1
Effective Time: 20090603
 
Supervalu Inc