ACETAMINOPHEN tablet, chewable

Acetaminophen by

Drug Labeling and Warnings

Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Alexso, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Acetaminophen 325 mg Chewable Gels

Alexso, Inc.

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Acetaminophen 325 mg Chewable Gels

DRUG FACTS

ACTIVE INGREDIENT

Acetaminophen 325mg

PURPOSE

Pain reliever/fever reducer

USES

Acetaminophen 325mg Chewable Gel 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 5 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
  
• skin reddening
  
• blisters
  
• rash

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include

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 2 chewable gels every 4 to 6 hours while symptoms last or as directed by a physician
  
• chew each chewable gel thoroughly before swallowing
  
• do not take more than 10 chewable gels in 24 hours
  
• do not take for more than 10 days unless directed by a physician
  
• take 1 chewable gel every 4 to 6 hours while symptoms last or as directed by a physician
  
• chew each chewable gel thoroughly before swallowing
  
• do not take more than 5 chewable gels in 24 hours
  
• do not take for more than 5 days unless directed by a physician

Children 6 to 11 years:

Children under 6 years: ask a physician

OTHER INFORMATION

• each chewable gel contains: sodium 7.44 mg.
  
• each chewable gel 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 325mg Chewable Gel is supplied in the following dosage form:

Fourteen (14) chewable gels per container

Made in USA

Rx Only

Manufactured for:

Alexso, Inc.

2317 Cotner Ave

Los Angeles, CA 90064

NDC: 50488-4325-1

Size: 14 Chewable Gels

PRINCIPAL DISPLAY PANEL

Acetaminophen 325 mg Chewable Gels
14 Orange Flavored Gummies
NDC: 50488-4325-1

INGREDIENTS AND APPEARANCE

ACETAMINOPHEN 
acetaminophen tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50488-4325
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MALTITOL (UNII: D65DG142WK)
SUCROSE (UNII: C151H8M554)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SUCRALOSE (UNII: 96K6UQ3ZD4)
NEOTAME (UNII: VJ597D52EX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CORN SYRUP (UNII: 9G5L16BK6N)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	25mm
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50488-4325-1	14 in 1 CONTAINER; Type 0: Not a Combination Product	11/01/2019

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)