Label: ACETAMINOPHEN liquid
- NDC Code(s): 69367-323-04, 69367-323-16
- Packager: Westminster Pharmaceuticals, LLC
- 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 May 6, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL teaspoonful)
This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 8 teaspoonfuls (40 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
If a skin reaction occurs, stop use and seek medical help right away.
Ask a doctor or pharmacist before use
if you are taking other drugs, including the blood thinner warfarin.
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.
- for more than 10 days for pain unless directed by a doctor
- for more than 3 days for fever unless directed by a doctor
- if you are allergic to acetaminophen or any of the inactive ingredients in this product.
Stop use and ask a doctor if
- new symptoms occur such as rash, hives, itching or hoarseness
- redness or swelling is present
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
- symptoms do not improve
These could be signs of a serious condition.
Do not exceed recommended dosage.
Taking more than the recommended dose (overdose) can cause serious health problems, including liver damage.
- adults and children 12 years of age and older: take 2 teaspoonfuls (10 mL) every 6 hours; do not exceed 8 teaspoonfuls (40 mL) in 24 hours
- children under 12 years of age: Under the direct guidance of a licensed professional, doctor, or pharmacist.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69367-323 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) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) 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:69367-323-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/05/2021 2 NDC:69367-323-16 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 05/05/2021 Labeler - Westminster Pharmaceuticals, LLC (079516651)