ACETAMINOPHEN- acetaminophen tablet, 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.

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Acetaminophen 325mg Chewable Gels

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:

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:

Children 6 to 11 years:

Children under 6 years: ask a physician

OTHER INFORMATION

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

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

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

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

ACETAMINOPHEN 
acetaminophen tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-4325
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScoreno score
ShapeROUNDSize25mm
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50488-4325-114 in 1 CONTAINER; Type 0: Not a Combination Product11/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34311/01/2019
Labeler - Alexso, Inc (963338061)

Revised: 12/2019
Document Id: 4de564c8-0419-48ff-abea-fafcd9b89ac4
Set id: 6c76f5ea-c6e5-4a10-813d-286733256028
Version: 1
Effective Time: 20191202
 
Alexso, Inc