duratuss ac
3e5ed178-d5d9-b8d4-e063-6394a90a91db
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
Active Ingredient
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ................................................... Antitussive
Dexbrompheniramine Maleate 1 mg ................................. Antihistamine
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 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
Warnings and Precautions (34071-1)
Warnings
Do not exceed recommended dosage.
Active Ingredient (55106-9)
Active ingredients
(in each 5 mL teaspoonful)
Codeine Phosphate 10 mg ................................................... Antitussive
Dexbrompheniramine Maleate 1 mg ................................. Antihistamine
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
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 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
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:07:18.912468 · Updated: 2026-03-14T23:10:35.893664