DOLO - NEUROBION ACETAMINOPHEN MAX EXTENDED-RELEASE 650 MG- acetaminophen tablet 
BENARD INDUSTRIES INC

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Benard Industries - Dolo-NeuroBion Acetaminophen Max, Extended-Release Tablets 650 mg (55959-179)

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen 650 mg

Purpose

Pain reliever/ Fever reducer

Uses

temporarily relieves minor aches and pains due to:

Warnings

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

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

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have liver disease


Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a 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(1-800-222-1222) right away. 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
  • take 2 tablets every 8 hours with water
  • swallow whole; do not crush, chew, split, or dissolve
  • do not take more than 6 caplets in 24 hours
  • do not use for more than 10 days unless directed by a doctor
under 18 years of age
  • ask a doctor

Other information

Inactive ingredients:

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions?

call 305-594-0480

PDP

DF1

DF2

DOLO - NEUROBION ACETAMINOPHEN MAX  EXTENDED-RELEASE 650 MG
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55959-179
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULE (Capsule-shaped) Size20mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55959-179-0330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154406/19/2023
Labeler - BENARD INDUSTRIES INC (106700321)

Revised: 6/2023
Document Id: fe7f4c90-c5ec-d662-e053-6294a90a3961
Set id: eaa9d094-ece6-41fd-97d9-0fdb0a45afd7
Version: 3
Effective Time: 20230619
 
BENARD INDUSTRIES INC