Label: ACETAMINOPHEN elixir
- NDC Code(s): 71399-0160-4, 71399-0160-6, 71399-0160-8
- Packager: Akron Pharma 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.
Drug Label Information
Updated February 4, 2023
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)
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.
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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
- 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.
- this product does not contain directions or complete warnings for adult use
- shake well before using
- find the right dose on chart below, if possible, use weight to dose; otherwise use age
- use only the enclosed dosing cup designed for use with this product.
- Do not use any other dosing device.
- if needed, repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by doctor.
Weight (lbs.) Age (years) dosage-teaspoonful (tsp.) under 24 under 2 ask a doctor 24 to 35 2 to 3 1 tsp or 5 mL 36 to 47 4 to 5 1 1/2 tsp or 7.5 mL 48 to 59 6 to 8 2 tsp or 10 mL 60 to 71 9 to 10 2 1/2 tsp or 12.5 mL 72 to 95 11 3 tsp or 15 mL
- Other information
- SPL UNCLASSIFIED SECTION
bubble gum flavor, citric acid, glycerin, polyethylene glycol 400, purified water, sodium citrate, saccharin sodium, sorbitol solution & sodium benzoate.
Questions or Comments?
Call (877) 225-6999 Monday - Friday 9AM-5PM EST
Akron Pharma, Inc.,
Fairfeld, NJ - 07004
Manufactured In USA
* This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol Elixir
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71399-0160 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) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SODIUM BENZOATE (UNII: OJ245FE5EU) Product Characteristics Color Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71399-0160-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 2 NDC:71399-0160-8 236 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 3 NDC:71399-0160-6 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/18/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 05/18/2021 Labeler - Akron Pharma Inc. (067878881) Registrant - Akron Pharma Inc. (067878881)