Label: CHILDRENS PAIN RELIEF DYE-FREE- acteaminophen suspension
- NDC Code(s): 67091-119-18
- Packager: WinCo Foods, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 11, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each 5 mL)
- Purpose
- 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
Allergy alert: Acetaminophen may cause severeskin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist drugs.
- 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.
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 (1-800-222-1222) right away. Quick medical attention is critical even if 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 dose
- do not take more than directed (see Overdose warning)
- shake well before using
- mL = milliliter
- use only the enclosed dosing cup designed for use with this product. Do not use any other dosing device.
- 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
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
Weight (lb) Age (year) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 5 mL 36-47 lbs 4-5 7.5 mL 48 - 59 lbs 6-8 10 mL 60 - 71 lbs 9-10 12.5 mL 72 - 95 lbs 11 years 15 mL *or as directed by a doctor
- Other information
- Inactive ingredients
- Questions?
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Principal Display Panel
**Compare to the active ingredient in Children's TYLENOL® Oral Suspension
ORAL SUSPENSION
Pain Relief
Children's
ACETAMINOPHEN 160 mg per 5 mL /
PAIN RELIEVER - FEVER REDUCER
Alcohol Free
Aspirin & Inuprofen Free
For Ages 2-11 Years
Dye Free
Grape Flavor
FL OZ (mL)
**This product is not manufactured or distributed by McNEIL CONSUMER HEALTHCARE, distributor of Children's TYLENOL® Oral Suspension.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AMD PRODUCT INFORMATION.
DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704
Comments or Question?
800-824-1706 www.wincofoods.com
- Package label
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INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF DYE-FREE
acteaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-119 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) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) Product Characteristics Color white Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67091-119-18 1 in 1 CARTON 12/12/2014 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 12/12/2014 Labeler - WinCo Foods, LLC (056098817)
