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Childrens Acetaminophen Oral Suspension Grape Flavor

Dosage form: suspension
Ingredients: Acetaminophen 160mg in 5mL
Labeler: We Care Distributor Inc.
NDC Code: 70005-040

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.

Drug Facts

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)

CHILDRENS ACETAMINOPHEN ORAL SUSPENSION  GRAPE FLAVOR
acetaminophen suspension
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70005-040
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen160 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorGRAPE (grape flavor) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:70005-040-0160 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34309/26/2016
Labeler - We Care Distributor Inc. (079832998)
Establishment
NameAddressID/FEIOperations
PURINE PHARMA LLC019950491manufacture(70005-040)

Revised: 09/2016
 
We Care Distributor Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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