Label: CHILDRENS PAIN RELIEF DYE-FREE- acteaminophen suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 67091-120-18 - Packager: WinCo Foods, LLC
- 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 December 9, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL teaspoon)
- Purpose
- KEEP OUT OF REACH OF CHILDREN
- Uses
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Warnings
- Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:
- more than 5 doses in 24 hours, which is maximum daily amount
- with other drugs containing acetaminophen
- Sore throat warning: if sore throat is severe, persists for more than 2 days, or 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.
- 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
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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.
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Directions
- do not give more than directed (see overdose warning)
- shake well before use
- this product does not contain directions or complete warnings for adult dose
- use only enclosed dosing cup
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) Age (yr) Dose (mL) under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48 - 59 lbs 6-8 years 10 mL 60 - 71 lbs 9-10 years 12.5 mL 72 - 95 lbs 11 years 15 mL - Other information
- Inactive ingredients
- PDP
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF DYE-FREE
acteaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-120 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) GLYCERIN (UNII: PDC6A3C0OX) MALTITOL (UNII: D65DG142WK) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color white Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-120-18 1 in 1 CARTON 12/12/2014 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/12/2014 Labeler - WinCo Foods, LLC (056098817)
