Label: CHILDRENS PAIN RELIEF- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 68016-178-04 - Packager: Chain Drug Consortium (Premier Value)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 October 28, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL, 1 teaspoon)
- 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
- 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
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 for more than 3 days. These could be signs of a serious condition.
Overdose Warning
Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.
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Directions
- this product does not contain directions or complete warnings for adult use
- shake well before using
- 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
- tsp = teaspoon, mL = milliliter
- if needed, 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 1 tsp or 5 mL 36-47 4-5 1½ tsps or 7.5 mL 48-59 6-8 2 tsps or 10 mL 60-71 9-10 2½ tsps or 12.5 mL 72-95 11 3 tsps or 15 mL - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-178 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 Xanthan Gum (UNII: TTV12P4NEE) Carboxymethylcellulose (UNII: 05JZI7B19X) Cellulose, Microcrystalline (UNII: OP1R32D61U) Methylparaben (UNII: A2I8C7HI9T) Propylparaben (UNII: Z8IX2SC1OH) Sucralose (UNII: 96K6UQ3ZD4) Saccharin Sodium (UNII: SB8ZUX40TY) Propylene Glycol (UNII: 6DC9Q167V3) Polyethylene Glycol 1450 (UNII: OJ4Z5Z32L4) High Fructose Corn Syrup (UNII: XY6UN3QB6S) Glycerin (UNII: PDC6A3C0OX) Sorbitol (UNII: 506T60A25R) D&C Red No. 33 (UNII: 9DBA0SBB0L) FD&C Red No. 40 (UNII: WZB9127XOA) Water (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor BUBBLE GUM, BANANA Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-178-04 1 in 1 CARTON 1 118 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 10/03/2014 Labeler - Chain Drug Consortium (Premier Value) (101668460) Registrant - davAgen Pharmaceutical, LLC (967545935) Establishment Name Address ID/FEI Business Operations davAgen Pharmaceutical, LLC 967545935 MANUFACTURE(68016-178) , PACK(68016-178) , LABEL(68016-178) , ANALYSIS(68016-178)
