Label: APAP ELIXER (ACETAMINOPHEN)- acetaminophen elixir
- 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 September 19, 2018
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- Active ingredient (in each 5 mL = 1 teaspoonful)
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 6 doses in 24 hours, which is the maximum daily amount
- child takes more than 5 doses in 24 hours, which is the maximum daily amount taken with other
drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using
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 non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product
Stop use and ask a doctor if:
- Pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
- new symptoms occur.
- redness or swelling is present.
These could be signs of a serious condition.
- shake well before using
- find the right dose on chart below, if possible, use weight to dose; otherwise use age
- dosage may be repeated every 4 hours, or as directed by your doctor
- do not use more than 5 doses in 24 hours
- do not use more than 5 days unless directed by a doctor.
Weight (lbs.) Age (years) dosage-teaspoonful (tsp.) under 24 under 2 consult Physician 24-35 2 to 3 1 tsp. (5 mL) 36-47 4 to 5 1 1/2 tsp. (7.5 mL) 48-59 6 to 8 2 tsp. (10 mL) 60-71 9 to 10 2 1/2 tsp. (12.5 mL) 72-95 11 to 12 3 tsp. (15 mL) over 95 12 to adult 4 tsp. (20 mL)
- Other information
- SPL UNCLASSIFIED SECTION
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
APAP ELIXER (ACETAMINOPHEN)
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-129 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) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color RED Score Shape Size Flavor CHERRY (CHERRY) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-129-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/20/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 08/20/2018 Labeler - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-129)