Indications and uses
temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Robafen AC™ Oral Solution
- Manufacturer
- Major Pharmaceuticals
- Effective date
- 2019-09-25
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:09:40
Label at a glance#
ProductRobafen AC
Active ingredientGUAIFENESIN, CODEINE PHOSPHATE
Label structure10 sections
Dosage and administration
take every 4 hours do not exceed 6 doses in 24 hours giving a higher dose than recommended by a doctor can result in serious side effects for a child. Do not exceed recommended dosage. not intended for use in children under 6 years of age TSP = teaspoonful Age Dose adults and children 12 years and over 2 TSP children 6 to under 12 years of age 1 TSP children under 6 years of age do not use
Storage and handling
each (5 mL) teaspoon contains : 4 mg sodium Tamper evident: Do not use this product if inner foil seal over the mouth of the bottle is torn, broken or missing. Keep container closed and store away from heat. DO NOT REFRIGERATE. Store at room temperature 20°-25°C (68°-77°F) Dispense in a tight, light-resistant container as defined in the USP.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredient (in each TSP (5 mL)) | Purposes |
|---|---|
| Codeine Phosphate, USP 10 mg | Cough suppressant |
| Guaifenesin USP 100 mg | Expectorant |
Uses
- temporarily relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritants
- helps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive
Warnings
Do not use
- in adults and children who have a chronic pulmonary disease or shortness of breath, or children who are taking other drugs, unless directed by a doctor.
- In children following a tonsillectomy and/or adenoidectomy as this could cause severe respiratory distress.
Ask a doctor before use if you have
- a cough with too much phlegm (mucus)
- a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are taking sedatives, tranquilizers and drugs used for depression, especially monoamine oxidase inhibitors (MAOIs). These combinations may cause greater sedation (drowsiness) than is caused by the product used alone.
Stop use and ask a doctor if
- cough lasts for more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These can be signs of a serious condition.
- may cause or aggravate constipation
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.
In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.
- Use of codeine-containing preparation is not recommended for children under 2 years of age
Directions
- take every 4 hours
- do not exceed 6 doses in 24 hours
- giving a higher dose than recommended by a doctor can result in serious side effects for a child. Do not exceed recommended dosage.
- not intended for use in children under 6 years of age
- TSP = teaspoonful
| Age | Dose |
|---|---|
| adults and children 12 years and over | 2 TSP |
| children 6 to under 12 years of age | 1 TSP |
| children under 6 years of age | do not use |
Other information
- each (5 mL) teaspoon contains : 4 mg sodium
- Tamper evident: Do not use this product if inner foil seal over the mouth of the bottle is torn, broken or missing.
- Keep container closed and store away from heat. DO NOT REFRIGERATE.
- Store at room temperature 20°-25°C (68°-77°F)
- Dispense in a tight, light-resistant container as defined in the USP.
Inactive ingredients
alcohol 3.5% v/v, artificial cherry flavor, caramel, citric acid, disodium EDTA, FD&C red # 40, glycerin, purified water, saccharin sodium, sodium benzoate, sorbitol solution
Questions or comments?
1-800-616-2471
SPL UNCLASSIFIED SECTION
Manufactured by:
Bio-Pharm, Inc. Levittown, PA 19057
Distributed by:
MAJOR
® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
NDC 0904-6479-16
Robafen AC™
Oral Solution CV
(GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION USP)
ANTITUSSIVE • EXPECTORANT
SUGAR FREE
Under Federal law Robafen AC is
available without a prescription.
Certain State laws may differ.
BULK CONTAINER - NOT FOR HOUSEHOLD USE.
TAMPER-EVIDENT
DO NOT REFRIGERATE
Manufactured by:
Bio-Pharm, Inc. Levittown, PA 19057
Distributed by:
MAJOR
® PHARMACEUTICALS
17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152
35-8045-16
REV 08/17 M-64
ONE PINT (473 mL)
MAJOR
®
PHARMACEUTICALS
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-6479-16 | ML - Milliliter | 0904-6479 | 6fe66ed2-0cb2-40b9-ae1e-a99f8eaa1f9b | 1 | 2018-02-20 |
Products#
Every source-derived product name is available through these pages.
- Robafen AC
- Guaifenesin and Codeine Phosphate
- ALCOHOL
- CHERRY
- CARAMEL
- ANHYDROUS CITRIC ACID
- EDETATE DISODIUM
- FD&C RED NO. 40
- GLYCERIN
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
- SORBITOL
- GUAIFENESIN
- CODEINE PHOSPHATE
- CODEINE ANHYDROUS
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-6479 | 0904-6479-16 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ALCOHOL | 3K9958V90M | IACT |
| CHERRY | BUC5I9595W | IACT |
| CARAMEL | T9D99G2B1R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9363d79b-6c58-57d7-e053-2995a90a1fc7 | e910cc7a-574a-4b3a-b32a-4ba077312873 | 2019-09-25 | Warnings | 9363d79b-6c58-57d7-e053-2995a90a1fc7 e910cc7a-574a-4b3a-b32a-4ba077312873 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.