Dolomax®

Dolomax®
SPL v2
SPL
SPL Set ID 520aee75-8b9a-4dcc-8970-75e122640e91
Route
ORAL
Published
Effective Date 2021-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Croscarmellose Sodium D&c Yellow No. 10 Aluminum Lake Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose Povidone, Unspecified Starch, Corn Silicon Dioxide Sodium Starch Glycolate Type A Stearic Acid Titanium Dioxide Triacetin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-07-05

Description

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

Purpose

Pain Reliever Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain Reliever

Cough suppressant

Expectorant

Nasal decongestant

Description

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

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

Section 42229-5

SEE NEW WARNINGS INFORMATION & DIRECTIONS

Cold/Cough Medicine

OTC EXCELLENCE IN NUTRITION TM

› 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

Section 50565-1

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.

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.

Packaging

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

Drug Facts

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

Active Ingredients (in Each Tablet)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Structured Label Content

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

Section 42229-5 (42229-5)

SEE NEW WARNINGS INFORMATION & DIRECTIONS

Cold/Cough Medicine

OTC EXCELLENCE IN NUTRITION TM

› 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

Section 50565-1 (50565-1)

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.

Purpose

Pain Reliever

Cough suppressant

Expectorant

Nasal decongestant

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.

Packaging

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

Drug Facts

Other Information (Other information)

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

Inactive Ingredients (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? (Questions or comments?)

1.800.595.0480 Mon-Fri: 9 AM to 4 PM

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)