Label: DYE FREE INFANTS PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 0363-7015-04
- Packager: WALGREENS
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 9, 2024
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions
Do not take more than directed.
See overdose warning
this product does not contain directions or complete warnings for adult use.
shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
push air out of syringe. Insert syringe tip into the bottle opening
flip bottle upside down. Pull yellow part of syringe to correct dose
dispense liquid slowly into child’s mouth, toward inner cheek
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours
replace cap tightly to maintain child resistanceWeight (lbs) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL *or as directed by a doctor
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DYE FREE INFANTS PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-7015 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 HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCROSE (UNII: C151H8M554) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color white (white to off white) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-7015-04 1 in 1 BOX 04/10/2024 1 60 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 04/10/2024 Labeler - WALGREENS (008965063) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 677604129 manufacture(0363-7015)