Duratuss Ac

Duratuss Ac
SPL v1
SPL
SPL Set ID 3e5ed178-d5d9-b8d4-e063-6394a90a91db
Route
ORAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Codeine Anhydrous (10 mg) Dexbrompheniramine (1 mg)
Inactive Ingredients
Glycerin Anhydrous Citric Acid Sorbitol Water Methylparaben Propylene Glycol Sucralose Sodium Citrate Sodium Benzoate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-08

Description

Active ingredients (in each 5 mL teaspoonful) Codeine Phosphate 10 mg ................................................... Antitussive Dexbrompheniramine Maleate 1 mg ................................. Antihistamine


Medication Information

Warnings and Precautions

Warnings

Do not exceed recommended dosage.

Indications and Usage

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
Dosage and Administration

Directions

Adults 12 and over: 10 mL every 4-6 hours

Not to exceed 60 mL in 24 hours or as directed by a doctor

Children 6-12: 5 mL every 4 hours,

Not to exceed 30 mL in 24 hrs or as directed by a doctor

Children under 6: Consult a doctor

Description

Active ingredients (in each 5 mL teaspoonful) Codeine Phosphate 10 mg ................................................... Antitussive Dexbrompheniramine Maleate 1 mg ................................. Antihistamine

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 50566-9

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur
Section 50567-7

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • may cause or aggravate constipation
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
Section 50568-5

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Section 50570-1

Do not use this product

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.

Section 51727-6

Inactive ingredients

Inactive ingredients Cherry flavor, citric acid, glycerin, propylene glycol, purified water,sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Section 51945-4

Section 53414-9

If pregnant or breastfeeding ask a health professional before use

Section 55105-1

Antihistamine

Antitussive

Section 55106-9

Active ingredients

(in each 5 mL teaspoonful)

Codeine Phosphate 10 mg ................................................... Antitussive

Dexbrompheniramine Maleate 1 mg ................................. Antihistamine

Section 60561-8

Other information

Store at room temperature 15°C-30°C (59°F-86°F)

Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

  • runny nose
  • sneezing
  • itching of nose or throat
  • itchy, watery eyes
  • cough due to minor throat and bronchial irritation
  • nasal congestion
  • reduces swelling of nasal passages
Dosage and Administration (34068-7)

Directions

Adults 12 and over: 10 mL every 4-6 hours

Not to exceed 60 mL in 24 hours or as directed by a doctor

Children 6-12: 5 mL every 4 hours,

Not to exceed 30 mL in 24 hrs or as directed by a doctor

Children under 6: Consult a doctor

Warnings and Precautions (34071-1)

Warnings

Do not exceed recommended dosage.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • nervousness, dizziness, or sleeplessness occur
  • cough or nasal congestion persists for more than 1 week, tends to recur, or is accompanied by a fever, rash or persistent headache. These could be signs of a serious condition.
  • new symptoms occur
Section 50567-7 (50567-7)

When using this product

  • excitability may occur, especially in children
  • may cause marked drowsiness
  • avoid alcoholic drinks
  • may cause or aggravate constipation
  • alcohol, sedatives, and tranquilizers may increase drowsiness effect
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • difficulty in urination due to the enlargement of the prostate gland
  • a cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • a cough that occurs with too much phlegm
  • a chronic pulmonary disease or shortness of breath, or children who are taking other drugs
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
Section 50570-1 (50570-1)

Do not use this product

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.

Section 51727-6 (51727-6)

Inactive ingredients

Inactive ingredients Cherry flavor, citric acid, glycerin, propylene glycol, purified water,sodium benzoate, sodium citrate, sorbitol solution, sucralose.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breastfeeding ask a health professional before use

Section 55105-1 (55105-1)

Antihistamine

Antitussive

Section 55106-9 (55106-9)

Active ingredients

(in each 5 mL teaspoonful)

Codeine Phosphate 10 mg ................................................... Antitussive

Dexbrompheniramine Maleate 1 mg ................................. Antihistamine

Section 60561-8 (60561-8)

Other information

Store at room temperature 15°C-30°C (59°F-86°F)

Questions? Comments? Serious side effects associated with use of this product may be reported to this number. Call 1-800-882-1041

Mon. - Fri. (8 a.m. to 5 p.m. CST).


Advanced Ingredient Data


Raw Label Data

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