Label: CHILDRENS PAIN AND FEVER suspension
- NDC Code(s): 0121-0975-08
- Packager: PAI Holdings, LLC dba PAI Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses temporarily:
-
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 nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
• if your child has ever had an allergic reaction to this product or any of its ingredients
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
-
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
• find right dose on chart below. If possible, use weight to
dose; otherwise, use age.
• remove the child protective cap and squeeze your child’s
dose into the dosing cup
• repeat dose every 4 hours while symptoms last
• do not give more than 5 times in 24 hoursWeight (lb) Age (yr) Dose (mL)* under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL 36-47 4-5 years 7.5 mL 48-59 6-8 years 10 mL 60-71 9-10 years 12.5 mL 72-95 11 years 15 mL *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 information
- Inactive ingredients
- Questions or Comments?
-
Principal Display Panel
Compare to the active ingredient in Children’s Tylenol® Oral Suspension**
Suspension Liquid
NDC 0121-0975-08
Children’s Pain & Fever
ACETAMINOPHEN
160 mg / 5 mL
Pain reliever; Fever reducer
Ages 2 to 11 years
Free of:
• Added Alcohol
• Aspirin
• Ibuprofen
Cherry Flavor
Use ONLY Enclosed Dosing Cup
Actual Bottle Size on Side Panel
8 FL OZ (237 mL)
Childrens Pain and Fever
-
INGREDIENTS AND APPEARANCE
CHILDRENS PAIN AND FEVER
childrens pain and fever suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0121-0975 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) BUTYLPARABEN (UNII: 3QPI1U3FV8) CITRIC ACID ACETATE (UNII: DSO12WL7AU) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL SOLUTION (UNII: 8KW3E207O2) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) 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:0121-0975-08 1 in 1 CARTON 11/21/2022 05/31/2024 1 237 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 11/21/2022 05/31/2024 Labeler - PAI Holdings, LLC dba PAI Pharma (044940096)