CHILDRENS ACETAMINOPHEN ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension

Childrens Acetaminophen Oral Suspension by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient

(in each 5 mL)
Acetaminophen 160 mg

Purpose

Acetaminophen
160 mg.............................Pain reliever/fever reducer

Uses

temporarily

• reduces fever
• 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 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 reach of children.

Enter section text here

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick 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.
• shake well before using
• mL = mililiter
• find right dose on chart below. If possible, use weight to dose; otherwise, use age.
• 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 (yr)        Dose (tsp or 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 (5mL) contains: sodium 3 mg
• store between 15-30˚C (59-86˚F)
• protect from freezing
• protect from light

Inactive ingredients

butyl paraben, carboxymethylcellulose sodium, cellulose, citric acid, D&C red # 33, FD&C blue # 1, flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

QUESTIONS OR COMMENTS?

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

Principal Display Panel

Childrens Acetaminophen Oral Suspension

Fever reducer
Pain reliever

Alcohol Free
Aspirin Free
Ibuprofen Free

Grape Flavor

Compare to active ingredient in Childrens Tylenol Fever reducer Pain reliever

2 FL OZ (60 mL)

INGREDIENTS AND APPEARANCE

CHILDRENS ACETAMINOPHEN ORAL SUSPENSION  GRAPE FLAVOR
acetaminophen suspension

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70005-040
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
SODIUM BENZOATE (UNII: OJ245FE5EU)
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)
SORBITOL (UNII: 506T60A25R)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE (grape flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70005-040-01	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/26/2016

Labeler - We Care Distributor Inc. (079832998)

Establishment
Name	Address	ID/FEI	Business Operations
PURINE PHARMA LLC		019950491	manufacture(70005-040)