Label: INFANTS PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 63941-321-04
- Packager: Best Choice (Valu Merchandisers Company)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 20, 2024
If you are a consumer or patient please visit this version.
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- 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 your child takes:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin 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, 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 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 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.
- do not take more than directed (see overdose warning)
- shake well before using
- mL= milliliter
- only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child
- remove cap, insert syringe into hole at top of bottle and turn upside down
- pull back syringe until filled to be prescribed level. If you pass the prescribed level, simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
- If needed, repeat dose every 4 hours while syptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- replace cap tightly to maintain child resistance
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
Weight (lb) Age (year) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL - Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
For ages 2 to 3 years
COMPARE TO THE ACTIVE INGREDIENT IN INFANTS' TYLENOL® ORAL SUSPENSION**
Infants'
PAIN & FEVER
Acetaminophen 160 mg per 5 mL
- pain reliever/fever reducer
- alcohol free
- aspirin free
- ibuprofen free
Cherry flavor
Use only enclosed syringe
Oral suspension
FL OZ (mL)
**This product is not manufactured or distributed by McNeil Consumer Healthcare, distributorof infants' Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.
PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO
5000 KANSAS AVE
KANSAS CITY, KS 66106
- Package Label
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INGREDIENTS AND APPEARANCE
INFANTS PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-321 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 BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63941-321-04 1 in 1 BOX 10/31/2015 1 59 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 Drug M013 10/31/2015 Labeler - Best Choice (Valu Merchandisers Company) (868703513)
