Label: PAIN AND FEVER- acetaminophen suspension
- NDC Code(s): 37808-946-16
- Packager: H E B
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 13, 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 your child takes
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if your child has ever had an allergic reaction to this product or any of its ingredients
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Directions
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- this product does not contain directions or complete warnings for adult use
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- do not give more than directed (see overdose warning)
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- shake well before using
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- mL = milliliter
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- find right dose on chart. If possible, use weight to dose; otherwise, use age.
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- push air out of syringe. Insert syringe tip into bottle opening.
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- flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
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- pull yellow part of syringe until it reaches and stays at the correct dose
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- dispense liquid slowly into child’s mouth, toward inner cheek
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- repeat dose every 4 hours while symptoms last
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- do not give more than 5 times in 24 hours
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- replace cap tightly to maintain child resistance
Dosing Chart
Weight (lb)
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.
- Other information
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Inactive ingredients
anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
- Questions or comments?
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Package/Label Principal Display Panel
Compare to Infants’ Tylenol® Oral Suspension active ingredient
Infants’ Pain & Fever
Acetaminophen 160 mg per 5 mL Oral Suspension
Pain Reliever/Fever Reducer
For Ages 2 to 3 Years
Use only with enclosed syringe.
See side panel for more information.
Alcohol Free
Aspirin Free
Ibuprofen Free
Grape Flavor
2 FL OZ (59 mL)
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INGREDIENTS AND APPEARANCE
PAIN AND FEVER
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37808-946 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) CARRAGEENAN (UNII: 5C69YCD2YJ) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color PURPLE Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37808-946-16 1 in 1 CARTON 12/01/2011 04/30/2025 1 59 mL in 1 BOTTLE, DROPPER; 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 12/01/2011 04/30/2025 Labeler - H E B (007924756)
