Label: ACETAMINOPHEN suspension
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Contains inactivated NDC Code(s)
NDC Code(s): 69517-627-17 - Packager: Healthlife of USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 10, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient (in each 5mL)
- 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
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.
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.
- Do not use
- Ask a doctor before use if your child has
- Ask a doctor or pharmacist before use if your child is
- When using this product do not exceed recommended dose
- Stop use and ask a doctor if
- Keep out of reach of children.
- Overdose warning:
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Directions
- this product does not contain directions or complete warnings for adult use
- mL=mililiter
- find right dose on chart below. If possible, use weight to dose; otherwise, use age.
- fill to dose level. Do not use any other dosing device
- dispense liquid slowly into child's mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- rinse the dosing device after each use
- do not give more than 5 times in 24 hours
- shake well before use
- do not give moer than directed.
Weight (lb) Age (year) Dose (mL)* Under 24 Under 2 years Ask a doctor 24-35 2-3 5mL * 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
- Inactive ingredients
- Questions or comments?
- Infant's Acetaminophen Oral SuspensionPain Reliever/ Fever Reducer
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-627 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 100 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) water (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color pink Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-627-17 1 in 1 CARTON 01/10/2018 1 15 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 not final part343 01/10/2018 Labeler - Healthlife of USA (079656178) Establishment Name Address ID/FEI Business Operations Kingston Pharma LLC 080386521 manufacture(69517-627)
