DoloMax Cold Cough ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE GUAIFENESIN PHENYLEPHRINE HYDROCHLORIDE BENARD INDUSTRIES INC FDA Approved 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
FunFoxMeds box
Substance Acetaminophen
Route
ORAL
Applications
M012
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each tablet) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg
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
Strengths
325 mg 10 mg 200 mg 5 mg
Treats Conditions
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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
Packaging

Packaging DoloMaxCold-133

Package Descriptions
  • Packaging DoloMaxCold-133

Overview

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

Indications & Usage

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

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Pain Reliever Cough suppressant Expectorant Nasal decongestant

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.

Storage & Handling

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

Questions

Questions or comments? 1.800.595.0480 Mon-Fri: 9 AM to 4 PM


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