OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen bar, chewable
Alexso, Inc

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.

Acetaminophen 160 mg Soft Chews

Alexso, Inc.

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Acetaminophen 160 mg Soft Chews

DRUG FACTS

ACTIVE INGREDIENT

Acetaminophen 160mg

PURPOSE

Pain reliever/fever reducer

USES

Acetaminophen 160mg Soft Chews is used for the temporarily relief of minor aches and pain due to the common cold, flu, headache, sore throat, toothache, and temporarily reduces fever.

WARNINGS

Liver warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours
  • child takes more than 10 doses in 24 hours
  • with other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
  • adults has 3 or more alcoholic drinks every day while using this product

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.

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 other drugs containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a physician or pharmacist.
  • if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Take under the supervision of a physician if you have liver disease, taking a blood thinning drug called warfarin, or have a history of high blood pressure or diabetes.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
  • 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.

If pregnant or breast-feeding, consult a physician or health professional before use.

KEEP OUT OF REACH OF CHILDREN

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DIRECTIONS

Do not take more than directed (see overdose warning)

Adults and children 12 years and over:

  • take 4 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
  • chew each soft chew thoroughly before swallowing
  • do not take more than 20 soft chews in 24 hours
  • do not take for more than 10 days unless directed by a physician

Children 6 to 11 years:

  • take 2 soft chews every 4 to 6 hours while symptoms last or as directed by a physician
  • chew each soft chew thoroughly before swallowing
  • do not take more than 10 soft chews in 24 hours
  • do not take for more than 5 days unless directed by a physician

Children under 6 years: ask a physician

OTHER INFORMATION

  • each soft chew contains: sodium 7.44 mg.
  • each soft chew contains: sugar 2g.
  • store in a cool dry place between 20-25°C (68-77°F).

Child Resistant Container; do not use if printed seal under cap is broken or missing.

Inactive ingredients:

hydroxypropyl betadex, seaweed extract (carrageenan), maltitol solution, sugar, sodium citrate, sodium chloride, sucralose, neotame, maltodextrin, glucose syrup, flavor, purified water.

HOW SUPPLIED

Acetaminphen 160mg Soft Chews is supplied in the following dosage form:

Fourteen (14) Soft Chews per container

Made in USA

Manufactured for:

Alexso, Inc.

2317 Cotner Ave

Los Angeles, CA 90064

NDC: 50488-4160-1

Size: 14 Soft Chews

PRINCIPAL DISPLAY PANEL

Acetaminophen 160 mg Soft Chews
14 Orange Flavored Gummies

Chewy Gummy BitesNDC:50488-4160-1

PRINCIPAL DISPLAY PANEL
Acetaminophen 160 mg Soft Chews
14 Orange Flavored Gummies
Chewy Gummy Bites
NDC:50488-4160-1
(click image for full-size original)
ACETAMINOPHEN acetaminophen bar, chewable
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-4160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 160 mg
Inactive Ingredients
Ingredient Name Strength
HYDROXYPROPYL BETADEX
CARRAGEENAN
MALTITOL
SUCROSE
SODIUM CITRATE
SODIUM CHLORIDE
SUCRALOSE
NEOTAME
MALTODEXTRIN
CORN SYRUP
WATER
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 25mm
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50488-4160-1 14 BAR, CHEWABLE in 1 CONTAINER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 11/01/2019
Labeler — Alexso, Inc (963338061)

Revised: 02/2020 Alexso, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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