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childrens acetaminophen by SUPERVALU INC.

Medically reviewed on February 13, 2017

Dosage form: tablet, chewable
Ingredients: ACETAMINOPHEN 160mg
Labeler: SUPERVALU INC.
NDC Code: 41163-494

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.

Equaline 44-449-children

Active ingredient (in each tablet)

Acetaminophen 160 mg

Purpose

Pain Reliever/fever reducer

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

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 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 dosage.

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 accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt 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 use
  • do not give more than directed
  • find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • chew before swallowing; this product will soften in mouth for ease of chewing
  • 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
 Weight (lb) Age (yr) Dose (Tablets)*
 Under 24
 Under 2
 Ask a doctor
 24-352-31
36-474-51 1/2
 48-59 6-8

 2

 60-71 9-10

 2 1/2

 72-95 11 3

 * or as directed by a doctor

Other information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • avoid high humidity
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

citric acid, crospovidone, D&C red #27 aluminum lake, D&C red #30 aluminum lake, dextrates hydrated, ethylcellulose, FD&C blue #1 aluminum lake, flavors, magnesium stearate, mannitol, polyethylene, stearic acid, sucralose

Questions or comments?

1-877-932-7948

Principal Display Panel

EQUALINE®

compare to Children's Tylenol® Meltaways® active ingredient**

NDC 41163-494-08

children's
acetaminophen
pain reliever/fever reducer

160mg, chewable tablets

for ages 2-11
grape flavor

• aspirin free
• ibuprofen free

24 tablets

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

100% Quality
GUARANTEED

Like it or let us make it right.
That's our quality promise.

877-932-7948
supervaluprivatebrands.com
DISTRIBUTED BY SUPERVALU INC.
EDEN PRAIRIE, MN 55344 USA

DOES NOT CONTAIN GLUTEN

**This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Children's Tylenol® Meltaways®.

50844  ORG101644908

Equaline 44-449


CHILDRENS ACETAMINOPHEN 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-494
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN160 mg
Inactive Ingredients
Ingredient NameStrength
CROSPOVIDONE 
D&C RED NO. 27 
D&C RED NO. 30 
DEXTRATES 
ETHYLCELLULOSES 
FD&C BLUE NO. 1 
MAGNESIUM STEARATE 
MANNITOL 
STEARIC ACID 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore2 pieces
ShapeROUNDSize16mm
FlavorGRAPEImprint Code44;449
Contains    
Packaging
#Item CodePackage Description
1NDC:41163-494-084 BLISTER PACK in 1 CARTON
16 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34301/28/2005
Labeler - SUPERVALU INC. (006961411)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(41163-494)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(41163-494)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(41163-494)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(41163-494)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(41163-494)

 
SUPERVALU INC.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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