Label: CHILDRENS PAIN RELIEF AND FEVER REDUCER ORAL SUSPENSION CHERRY- acetaminophen suspension
- NDC Code(s): 83474-001-04
- Packager: Puro Pharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 8, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- 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 acetaminophenAllergy 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
-
OVERDOSAGE
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. (1-800-222-1222) Quick medical attention is critical
for adults as well as for children even if you
do not notice any signs or symptoms. -
DOSAGE & ADMINISTRATION
Directions
■ this product does not contain directions or
complete warnings for adult use.
■ shake well before using
■ mL = milliliter; tsp = teaspoonful
■ find the right dose on the chart below. If possible, use
weight to dose, otherwise, use age.
■ if needed, repeat dose every 4 hours while
symptoms last
■ do not give more than 5 times in 24 hours
■ do not give for more than 5 days unless directed
by a doctor.Weight (lb) Age (yr) Dose (mL or tsp)* under 24 under 2 years ask a doctor 24-35 2 - 3 years 5 mL (1 tsp) 36-47 4 - 5 years 7.5 mL (1 1/2 tsp) 48-59 6 - 8 years 10 mL (2 tsp) 60-71 9 - 10 years 12.5. mL (2 1/2 tsp) 72-95 11 years 15 mL (3 tsp) *or as directed by a doctor
Attention: use only enclosed dosing cup specifically
designed for use with this product. Do not use any
other dosing device. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Package Labeling PURO PHARMA Children's Pain & Fever Acetaminophen Oral Suspension Cherry Flavor
PURO
PHARMA NDC 83474-001-04
COMPARE TO THE
ACTIVE INGREDIENT
IN CHILDREN'S TYLENOL
ORAL SUSPENSION*
PURO
PHARMA
Children's Pain & Fever
Acetaminophen
Oral Suspension
Pain reliever
Fever Reducer
• Ibuprofen Free
• Aspirin Free
• For Ages 2 to 114 FL OZ (118 mL)
160 mg per 5 mL
Cherry Flavor
This product is not manufactured or distributed by McNeil
Consumer Healthcare, distributor of Children's Tylenol®
Oral Suspensin
Distributed by:
Puro Pharma Inc.
42 Catharine St. Poughkeepsie, NY 12601
Info@puro-pharma.com
BX-175
res
-
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN RELIEF AND FEVER REDUCER ORAL SUSPENSION CHERRY
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83474-001 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) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color red Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83474-001-04 1 in 1 CARTON 03/28/2024 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 03/28/2024 Labeler - Puro Pharma Inc. (128518845)