DOLOMAX COLD COUGH- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan tablet 
BENARD INDUSTRIES 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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DoloMax Cold

Uses:

temporarily relievess these symptoms due to the common cold:

  • nasal congestion
  • headache
  • minor aches and pains chest congestion
  • cough
  • sore throat
  • helps losen phelgm (mucus) and thin bronchial secretions to drain broncial tubes and makes coughs more productive
  • temporily reduces fever

Active Ingredients

Active Ingredient (in each tablet)                                       Purpose 
 Acetaminophen 325 mg Pain Reliever/Fever Reducer
 Guaifenesin 200mg Expectorant
 Phenylephrine HCl 5mg Decongestant
 Dextromethorphan HBr 15mg Antitusive

Warnings

Liver Warning: this product contains acetaminophen. The maximum daily dose of this product is 8 tablets (2,600 mg acetaminophen) in 24 hours. Severe liver damage may occur if you take

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Sore throat warning: if sore throat is severe, persists more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomitting, consults a doctor promptly.

Do not use

  • with any other drugs containing acetaminophen (prescription orr non prescription) if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certian drugs for depression, psychiatric ie emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription contains MAOI, ask a doctoror or pharmacist before taking this product.
  • if you have ever had an allergic reactions to this prodcut or any of its ingredients

ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarge prostate gland
  • persistsent r chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much pllegm (mucus)

ASk a doctor or pharmacist before use if you are taking sedatives, tranquillizers or the blood thinning drug warfarin.

When using this product do not exceedd recommended dose.

Stop use and ask a doctor if

  • nervouseness, dizziness or sleeplessness occurs
  • oain, cough, or nasal congestion gets worse or last more than 7 days
  • fever gets worse or lasts for more than 3 days
  • redness or sweeling is present
  • new symptons occur
  • cough comes bacj or occurs with rash or headache. 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 madical help or contact a Poison Control Center immediately (1-800-222-1222). Quick medical attention is critival for adults as well as for children even if you do not notice any signs or symptons.

Directions

do not use more than directed (see overdose warning)
Adults and children 12 years and over

 take 2 tablets every 6-8 hours.

 do not take more than 8 tablets in 24 hours

Children under 12 years consult a doctor

Other Information
do not use if blister package is torn, cut or open
 store at room temperature  avoid excessive heat and humidity

Inactive Ingredients: Maltodextrin, Microcrystalline Cellulose, Povidone, Sodium
Starch Glycolate, Starch, Stearic Acid.

Questions / COmments: (305)594-0480

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

  • temporarily relieves these symptoms due to the common cold:
  • nasal congestion
  • headache
  • minor aches and pains chest congestion
  • cough
  • sore throat
  • helps losen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
  • temporarily reduces fever

Label DoloMax Cold

DOLOMAX COLD COUGH 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55959-132
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapecapsuleSize6mm
FlavorgrapeImprint Code FR12
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55959-132-011 in 1 BOX12/01/201710/31/2022
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/01/201710/31/2022
Labeler - BENARD INDUSTRIES INC (106700321)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc151051757manufacture(55959-132)

Revised: 7/2021
 
BENARD INDUSTRIES INC