DOLOMAX COLD COUGH- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan tablet

DoloMax Cold Cough by

Drug Labeling and Warnings

DoloMax Cold Cough by is a Otc medication manufactured, distributed, or labeled by BENARD INDUSTRIES INC, ULTRAtab Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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.

PREGNANCY

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

• 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 INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DOLOMAX COLD COUGH 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55959-132
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
povidone (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	capsule	Size	6mm
Flavor	grape	Imprint Code	FR12
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55959-132-01	1 in 1 BOX	12/01/2017
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/01/2017

Labeler - BENARD INDUSTRIES INC (106700321)

Establishment
Name	Address	ID/FEI	Business Operations
BENARD INDUSTRIES INC		106700321	label(55959-132)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc		151051757	manufacture(55959-132)