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
Guaifenesin and Codeine Phosphate
- Manufacturer
- Cardinal Health 107, LLC
- Effective date
- 2026-06-02
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- weekly-update
- Hydrated at
- 2026-07-17 21:43:36
Label at a glance#
ProductGuaifenesin and Codeine Phosphate
Active ingredientCODEINE PHOSPHATE, GUAIFENESIN
Label structure10 sections
Dosage and administration
• take every 4 hours • do not exceed 6 doses in 24 hours • a special measuring device should be used to give an accurate dose of this product to children under 6 years of age • giving a higher dose than recommended by a doctor can result in serious side effects for a child adults and children 12 years and over 10 mL (2 teaspoonfuls) children 6 to under 12 years of age 5 mL (1 teaspoonful) children under 6 years of...
Storage and handling
• Sodium Content: 5 mg/5 mL • Tamper evident: Do not use if seal under cap is broken or missing • Keep container closed and store away from heat • Store at 20°- 25°C (68°-77°F) Overbagged with 5 x 5 mL unit-dose cups in each bag, NDC 55154-5791-5 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients in each 5 mL (teaspoonful) | 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.
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 aretaking 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
- a special measuring device should be used to give an accurate dose of this product to children under 6 years of age
- giving a higher dose than recommended by a doctor can result in serious side effects for a child
adults and children 12 years and over | 10 mL (2 teaspoonfuls) |
children 6 to under 12 years of age | 5 mL (1 teaspoonful) |
children under 6 years of age | Consult a doctor |
Other information
- Sodium Content:5 mg/5 mL
- Tamper evident: Do not use if seal under cap is broken or missing
- Keep container closed and store away from heat
- Store at 20°- 25°C (68°-77°F)
Overbagged with 5 x 5 mL unit-dose cups in each bag, NDC 55154-5791-5
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Inactive ingredients
Citric acid, edetate disodium, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, flavor, glycerin, menthol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium saccharin and sorbitol.
Questions or comments?
Call 1-800-845-8210 or visit paipharma.com
Serious side effects associated with use of this product may be reported to this number.
.
Distributed By:
Cardinal Health
Dublin, OH 43017
LC8458470424
X07751600 R10/15 F1775050221 F1775100221
Principal Display Panel
CV
NDC 55154-5791-5
GUAIFENESIN AND CODEINE
PHOSPHATE ORAL SOLUTION USP
100 mg/10 mg per 5 mL
5 CUPS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0055154579155 | GTIN-13: 0055154579155 EAN-13: 0055154579155 GTIN-12: 055154579155 UPC-A: 055154579155 GTIN storage (14 digits): 00055154579155 | 2175415b-f07e-50a6-e063-6394a90acabe-00.jpg |
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0121-1775-00 | ML - Milliliter | 0121-1775 | fdafec21-258c-4805-9ff7-66930e2484d4 | 1 | 2017-08-11 |
| 0121-1775-05 | ML - Milliliter | 0121-1775 | 4eac12b0-97b2-4ef1-bef3-888760717dfa | 1 | 2012-07-24 |
| 0121-1775-10 | ML - Milliliter | 0121-1775 | fe8b87eb-c801-465e-91f8-5a36471e2a43 | 1 | 2012-07-24 |
| 0121-1775-40 | ML - Milliliter | 0121-1775 | 83b2dba4-69f5-4ad4-ad62-88c4211f6184 | 1 | 2024-02-14 |
Products#
Every source-derived product name is available through these pages.
- Guaifenesin and Codeine Phosphate
- CODEINE PHOSPHATE
- CODEINE ANHYDROUS
- GUAIFENESIN
- SODIUM CITRATE, UNSPECIFIED FORM
- EDETATE DISODIUM
- FD&C BLUE NO. 1
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GLYCERIN
- MENTHOL, UNSPECIFIED FORM
- PROPYLENE GLYCOL
- WATER
- SODIUM BENZOATE
- ANHYDROUS CITRIC ACID
- SACCHARIN SODIUM
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55154-5791 | 55154-5791-5 |
| 0121-1775 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 4 | 2025-10-03 | full-release | 2026-06-01 01:21:41 |
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 |
|---|---|---|---|---|---|---|
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | Cardinal Health 107, LLC | a9130f36-4761-4e6b-a383-eca3db06ea93 | 2026-06-02 | Warnings | 55154-5791-5 55154-5791 55154579105 54a012fb-214d-4dba-bf91-90ca8ee293c2 a9130f36-4761-4e6b-a383-eca3db06ea93 |
| Guaifenesin and Codeine Phosphate | GUAIFENESIN AND CODEINE PHOSPHATE | PAI Holdings, LLC | 88d0994c-4270-4408-8837-bd97510b2118 | 2024-09-06 | Warnings | 0121-1775 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.