Label: ACETAMINOPHEN liquid
- NDC Code(s): 72091-004-01
- Packager: SAMJAN GROUP INC.
- 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.
Updated March 17, 2021
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
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 • taken 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.
- Do not use
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
- Stop use and ask a doctor if
- Keep out of reach of children.
• do not take more than directed
This product does not contain directions or complete warnings for adult use.
• find dose in chart below, if possible, use weight to dose, otherwise use age
• dosage may be repeated every 4 hours as needed, or as directed by a doctor
• do not give more than 5 doses in 24 hours • 5 milliliters (mL) = 1 teaspoon
ask a doctor
- Other information
- Inactive ingredients:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72091-004 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) Product Characteristics Color red Score Shape Size Flavor FRUIT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72091-004-01 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/17/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 03/17/2021 Labeler - SAMJAN GROUP INC. (080313200)