FDA Label for Dolomax Cold Cough
View Indications, Usage & Precautions
Dolomax Cold Cough Product Label
The following document was submitted to the FDA by the labeler of this product Benard Industries Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Otc - Keep Out Of Reach Of Children
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
Packaging
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