Comtrex Cough and Cold

Manufacturer
Dr. Reddy's Laboratories Inc.
Effective date
2016-06-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:40:03

Label at a glance#

ProductComtrex Cough and Cold Day/Night
Active ingredientAcetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride, Chlorpheniramine Maleate
Label structure10 sections

Indications and 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)

Dosage and administration

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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN see end flap for expiration date and lot number store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

  • 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)

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

  • 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

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Cold Night only)

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • see end flap for expiration date and lot number
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients (Cold Day)

INACTIVE INGREDIENT SECTION

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)

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

1-800-790-6417

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - Kit Carton

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55741-52455741-524-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Source Document#

Source XML

openFDA label cross-check#

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Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
298e5dd0-dc7d-5d3b-e063-6294a90a9fe53dad0c43-49dc-458a-a34b-331c5f8b64152024-12-18WarningsExact identifier
spl set id: 3dad0c43-49dc-458a-a34b-331c5f8b6415

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.