Label: DOLOMAX COLD COUGH- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet
- NDC Code(s): 55959-133-01
- Packager: BENARD INDUSTRIES INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 31, 2024
If you are a consumer or patient please visit this version.
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- Drug Facts
- Active ingredients (in each tablet)
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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 ingredientsAsk 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.
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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 PainREAD 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 33172www.otcpharmausa.com
- Packaging
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INGREDIENTS AND APPEARANCE
DOLOMAX COLD COUGH
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tabletProduct 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 Drug M012 07/05/2021 Labeler - BENARD INDUSTRIES INC (106700321)

