Label: COMTREX COUGH AND COLD DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate kit
- NDC Code(s): 55741-524-24
- Packager: Dr. Reddy's Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated June 15, 2016
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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ACTIVE INGREDIENT
Active ingredients (in each caplet)
(Cold Multi-Symptom Day)Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant Active ingredients (in each caplet)
(Cold Multi-Symptom Night)Purpose Acetaminophen 325 mg Pain reliever/fever reducer Chlorpheniramine maleate 2 mg Antihistamine Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant -
Uses
- temporarily relieves these common cold/flu symptoms:
- headache
- minor aches and pains
- nasal congestion
- sinus congestion and pressure
- sore throat
- cough
- sneezing and runny nose (Cold Night only)
- helps clear nasal passages
- temporarily reduces fever
- promotes nasal and sinus drainage (Cold Day only)
- relieves cough to help you sleep (Cold Night only)
- temporarily relieves these common cold/flu symptoms:
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Warnings
Liver warning
This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (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
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.
Ask a doctor before use if you have
- diabetes
- high blood pressure
- heart disease
- thyroid disease
- liver disease
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- cough that occurs with too much phlegm (mucus)
- glaucoma (Cold Night only)
- a breathing problem such as emphysema or chronic bronchitis (Cold Night only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Cold Night only)
When using this product
- do not exceed recommended dosage
- avoid alcoholic drinks (Cold Night only)
- marked drowsiness may occur (Cold Night only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Cold Night only)
- excitability may occur, especially in children (Cold Night only)
- be careful when driving a motor vehicle or operating machinery (Cold Night only)
Stop use and ask a doctor if
- fever gets worse or lasts more than 3 days
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- a persistent cough may be a sign of a serious condition. If cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache, consult a doctor.
- redness or swelling is present
These could be signs of a serious condition.
Overdose warning
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
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do not take more than directed
(see overdose warning) - adults and children 12 years and over:
- take 2 caplets every 4 hours
- swallow whole - do not crush, chew, or dissolve
- do not take more than 10 caplets in 24 hours
- children under 12 years: ask a doctor
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do not take more than directed
- Other information
- Inactive ingredients (Cold Day)
- Inactive ingredients (Cold Night)
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - Kit Carton
NDC 55741-524-24
COMTREX®
COLD & COUGHDAY
Acetaminophen
- ✓
- Pain Reliever
- ✓
- Fever Reducer
Dextromethorphan HBr
- ✓
- Cough Suppressant
Phenylephrine HCl
- ✓
- Nasal Decongestant
12 COATED CAPLETS
NIGHT
Acetaminophen
- ✓
- Pain Reliever
- ✓
- Fever Reducer
Chlorpheniramine maleate
- ✓
- Antihistamine
Dextromethorphan HBr
- ✓
- Cough Suppressant
Phenylephrine HCl
- ✓
- Nasal Decongestant
12 COATED CAPLETS
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INGREDIENTS AND APPEARANCE
COMTREX COUGH AND COLD DAY/NIGHT
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55741-524 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55741-524-24 1 in 1 CARTON; Type 0: Not a Combination Product 05/24/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 12 Part 1 of 2 COMTREX COLD MULTI-SYMPTOM DAY CAPLET
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coatedProduct Information 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 Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Inactive Ingredients Ingredient Name Strength starch, corn (UNII: O8232NY3SJ) croscarmellose sodium (UNII: M28OL1HH48) crospovidone (UNII: 68401960MK) D&C yellow no. 10 (UNII: 35SW5USQ3G) FD&C yellow no. 6 (UNII: H77VEI93A8) aluminum oxide (UNII: LMI26O6933) hypromelloses (UNII: 3NXW29V3WO) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) polydextrose (UNII: VH2XOU12IE) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) sucralose (UNII: 96K6UQ3ZD4) titanium dioxide (UNII: 15FIX9V2JP) triacetin (UNII: XHX3C3X673) Product Characteristics Color YELLOW Score no score Shape OVAL (oblong) Size 16mm Flavor Imprint Code Cx Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 05/24/2015 Part 2 of 2 COMTREX COLD MULTI-SYMPTOM NIGHT CAPLET
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate tablet, coatedProduct Information 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 Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride 5 mg Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate 2 mg Inactive Ingredients Ingredient Name Strength starch, corn (UNII: O8232NY3SJ) crospovidone (UNII: 68401960MK) FD&C blue no. 1 (UNII: H3R47K3TBD) FD&C blue no. 2 (UNII: L06K8R7DQK) aluminum oxide (UNII: LMI26O6933) magnesium stearate (UNII: 70097M6I30) cellulose, microcrystalline (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) polyvinyl alcohol (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) silicon dioxide (UNII: ETJ7Z6XBU4) sodium starch glycolate Type A corn (UNII: AG9B65PV6B) stearic acid (UNII: 4ELV7Z65AP) sucralose (UNII: 96K6UQ3ZD4) talc (UNII: 7SEV7J4R1U) titanium dioxide (UNII: 15FIX9V2JP) Product Characteristics Color BLUE Score no score Shape OVAL (oblong) Size 16mm Flavor Imprint Code Cx Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 05/24/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/24/2016 Labeler - Dr. Reddy's Laboratories Inc. (802315887)