COMTREX COUGH AND COLD   DAY/NIGHT- acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate 
Dr. Reddy's Laboratories Inc.

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.

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Comtrex® Cough & Cold
Day/Night

Drug Facts

Active ingredients (in each caplet)
(Cold Multi-Symptom Day)
Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant
Active ingredients (in each caplet)
(Cold Multi-Symptom Night)
Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Chlorpheniramine maleate 2 mgAntihistamine
Dextromethorphan HBr 10 mgCough suppressant
Phenylephrine HCl 5 mgNasal decongestant

Uses

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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.

Directions

Other information

Inactive ingredients (Cold Day)

corn starch, croscarmellose sodium, crospovidone, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, flavor, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, povidone, silica gel, stearic acid, sucralose, titanium dioxide, triacetin

Inactive ingredients (Cold Night)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silica gel, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-790-6417

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 55741-524-24

COMTREX®
COLD & COUGH

DAY

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

PRINCIPAL DISPLAY PANEL - Kit Carton
COMTREX COUGH AND COLD   DAY/NIGHT
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-524
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55741-524-241 in 1 CARTON; Type 0: Not a Combination Product05/24/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BLISTER PACK 12 
Part 21 BLISTER PACK 12 
Part 1 of 2
COMTREX COLD MULTI-SYMPTOM DAY CAPLET 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorYELLOWScoreno score
ShapeOVAL (oblong) Size16mm
FlavorImprint Code Cx
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2015
Part 2 of 2
COMTREX COLD MULTI-SYMPTOM NIGHT CAPLET 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride, and chlorpheniramine maleate tablet, coated
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen325 mg
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan Hydrobromide10 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine Hydrochloride5 mg
Chlorpheniramine Maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine Maleate2 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorBLUEScoreno score
ShapeOVAL (oblong) Size16mm
FlavorImprint Code Cx
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/24/2016
Labeler - Dr. Reddy's Laboratories Inc. (802315887)

Revised: 6/2016
Document Id: 01a04fc3-a1d7-b8eb-6c0f-08ab1fa59a67
Set id: 3dad0c43-49dc-458a-a34b-331c5f8b6415
Version: 3
Effective Time: 20160615
 
Dr. Reddy's Laboratories Inc.