OTC Medication Information: Childrens Acetaminophen Oral Suspension Grape Flavor

CHILDRENS ACETAMINOPHEN ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension
We Care Distributor 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.

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 acetaminophenSore 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

  • 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.

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 FreeIbuprofen Free

Grape Flavor

Compare to active ingredient in Childrens Tylenol Fever reducer Pain reliever

2 FL OZ (60 mL)

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 160 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE
butylparaben
carboxymethylcellulose sodium
CELLULOSE, MICROCRYSTALLINE
CITRIC ACID MONOHYDRATE
GLYCERIN
HIGH FRUCTOSE CORN SYRUP
PROPYLENE GLYCOL
SORBITOL
SUCRALOSE
XANTHAN GUM
D&C RED NO. 33
FD&C BLUE NO. 1
Product Characteristics
Color Score
Shape Size
Flavor GRAPE (grape flavor) Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70005-040-01 60 mL in 1 BOTTLE, PLASTIC None
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 Operations
PURINE PHARMA LLC 019950491 manufacture (70005-040)

Revised: 09/2016 We Care Distributor Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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