DOLOMAX COLD COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride 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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg

Purpose

Pain Reliever
Cough suppressant
Expectorant
Nasal decongestant

Uses

For the temporary relief of the following cold/flu symptoms:
minor aches and pains  headache  sore throat  nasal congestion  cough 
 helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive 
 temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 10 tablets (3,250 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
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:  skin reddening  blisters  rash
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 any other drug containing acetaminophen (prescription or nonprescription). 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) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if 
liver disease   high blood pressure   thyroid disease   diabetes   trouble urinating due to an enlarged prostate gland   persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema   cough that occurs with too much phlegm (mucus)

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

When using this product do not exceed recommended dose

Stop use and ask a doctor if
nervousness, dizziness, or sleeplessness occur  pain, nasal congestion or cough gets worse or lasts more than 7 days  fever gets worse or lasts more than 3 days   redness or swelling is present  new symptoms occur   cough comes back or occurs with rash or headache that lasts.
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 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 tablets every 4 hours; swallow whole; do not crush, chew or dissolve; do not take more than 10 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

each tablet contains: sodium 2 mg  store at 20°-25°C (68°-77°C)

Inactive ingredients

croscarmellose sodium, D&C Yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, pregelatinized starch, silicon dioxide, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

Questions or comments?

1.800.595.0480 Mon-Fri: 9 AM to 4 PM

SPL UNCLASSIFIED SECTION

SEE NEW WARNINGS INFORMATION & DIRECTIONS

Cold/Cough Medicine

OTC EXCELLENCE IN NUTRITIONTM

› Head & Body Aches
› Nasal Congestion
› Fever
› Sore Throat
› Cough
› Sinus Pain

READ AND KEEP CARTON FOR NEW WARNINGS INFORMATION & DIRECTIONS.

SEE ACETAMINOPHEN WARNINGS

RETAIN CARTON FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF BLISTER IS CUT OR BROKEN

Distributed by
OTC Pharmaceutical Products
10860 Nw 27th St , Doral , FL 33172

www.otcpharmausa.com

Packaging

INGREDIENTS AND APPEARANCE

DOLOMAX COLD COUGH 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55959-133
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	yellow (light yellow)	Score	no score
Shape	capsule	Size	19mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55959-133-01	1 in 1 BOX	07/05/2021
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	07/05/2021

Labeler - BENARD INDUSTRIES INC (106700321)