CHILDRENS ACETAMINOPHEN- acetaminophen suspension

Childrens Acetaminophen by

Drug Labeling and Warnings

Childrens Acetaminophen by is a Otc medication manufactured, distributed, or labeled by We Care Distributors Inc., PURINE PHARMA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient (in each 5 mL)

Acetaminophen 160 mg

Purpose

Acetaminophen.............................Pain reliever/fever reducer

Uses

• temporarily reduces fever
• temporarily 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 non-prescription). 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 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 dose (see overdose warning)

Stop use and ask a doctor if

new symptoms occur
redness or swelling is present
pain gets worse or lasts more than 5 days
fever gets worse or lasts more than 3 days
These could be signs of a serious condition.

Keep out of the reach of children.

Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical attention is critical even if you do not notice any signs or
symptoms.

Directions

this product does not contain directions or complete warnings for adult use.
shake well before using

mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
use only enclosed dosing cup designed for use with this product. Do not use any other dosing device.
 repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor

Weight (lb.)                     Age (yrs.)                     Dose (mL*)
under 24                          under 2                      ask a doctor
24-35                                 2-3                             5 mL
36-47                                 4-5                             7.5 mL
48-59                                 6-8                             10 mL
60-71                                 9-10                           12.5 mL
72-95                                 11                              15 mL

* always check with your doctor before administering medicine to your infant/child

Other information

• each teaspoon (mL) contains: Sodium 3 mg
• store between 150-300C (590-860F)
• Protect from freezing
• Protect from light

Inactive Ingredients

butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red #40, flavor, glycerin, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sodium saccharin, sorbitol, sucralose, xanthan gum

Questions or Comments?

1-888-705-WECARE (Mon-Fri 9am-5pm EST) or www.wecaredistributor.com

Principal Display Panel

Compare to the active ingredient in Children's Tylenol®*
Children's Pain Relief
Suspension Liquid
Cherry Flavor
For ages 2 to 11
2 FL OZ (60 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN 
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-041
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
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
FD&C Red No. 40 (UNII: WZB9127XOA)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-041-01	1 in 1 CARTON	08/17/2016
1		60 mL in 1 BOTTLE, PLASTIC; 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	08/17/2016

Labeler - We Care Distributors Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-041)