Label: CHILDRENS ACETAMINOPHEN ORAL SUSPENSION GRAPE FLAVOR- acetaminophen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 70005-040-01 - Packager: We Care Distributor Inc.
- Category: HUMAN OTC DRUG LABEL
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 Label Information
Updated September 26, 2016
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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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
- Ask a doctor before use if your child has
- Ask a doctor or pharmacist before use if your child
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Overdose Warning
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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 mLalways check with your doctor before administering medicine to your infant/child
- Other information
- Inactive ingredients
- QUESTIONS OR COMMENTS?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHILDRENS ACETAMINOPHEN ORAL SUSPENSION GRAPE FLAVOR
acetaminophen suspensionProduct 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)