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.
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
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