CODEINE-GUAIFENESIN
- Manufacturer
- Direct Rx
- Effective date
- 2022-03-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:06:57
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each 5 mL = 1 tsp) Purpose
Codeine phosphate, USP 10 mg Antitussive
Guaifenesin, USP 100 mg Expectorant
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
temporarily relieves:
cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
your cough to help you sleep
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
WARNINGS SECTION
Ask your doctor before use if
you have a persistent cough, this may be a sign of a serious condition
you have a persistent cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
you have a cough that is accompanied by excessive phlegm (mucus)
you have chronic pulmonary disease or shortness of breath
giving to a child who is taking other drugs
When using this product
giving a higher dose than recommended by a doctor could result in serious side effects for your child. A special measuring device should be used to give an accurate dose of this product to children under 6 years of age.
may cause or aggravate constipation
Stop use and ask a doctor if
symptoms do not improve within 7 days, tend to recur or are accompanied by fever and rash or persistent headache. These may be symptoms of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
OTC - WHEN USING SECTION
do not exceed 6 doses in 24 hours.
Adults and children 12 years of age and over: 2 tsp (10 mL) every 4 hours, or as directed by a doctor.
Children 6 to under 12 years of age: 1 tsp (5 mL) every 4 hours, or as directed by a doctor.
Children under 6 years of age: Consult a doctor.
OTHER SAFETY INFORMATION
Store at controlled room temperature 15°-30°C (59°-86°F).
You may report side effects by calling 1-844-221-7294 or FDA at 1-800-FDA-1088.
INACTIVE INGREDIENT SECTION
Cherry Flavor, Citric Acid Anhydrous, Glycerin, Masking Agent, Propylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate, Sorbitol Solution, Sucralose.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72189-337-04 | ML - Milliliter | 72189-337 | f536c6f6-5f2d-4d67-b778-31af8551250b | 1 | 2022-04-06 |
Products#
Every source-derived product name is available through these pages.
- CODEINE-GUAIFENESIN
- codeine phosphate and guaifenesin solution
- PROPYLENE GLYCOL
- GUAIFENESIN
- CODEINE PHOSPHATE
- CODEINE ANHYDROUS
- GLYCERIN
- CITRIC ACID MONOHYDRATE
- WATER
- SODIUM BENZOATE
- SODIUM CITRATE, UNSPECIFIED FORM
- SORBITOL
- SUCRALOSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 72189-337 | 72189-337-04 |
| 69367-272 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CODEINE PHOSPHATE | GSL05Y1MN6 | ACTIB |
| GLYCERIN | PDC6A3C0OX | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CITRATE, UNSPECIFIED FORM | 1Q73Q2JULR | IACT |
| SORBITOL | 506T60A25R | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
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 |
|---|---|---|---|---|---|---|
| 074b7240-abe5-8c7b-e063-6294a90a0b30 | d9a75569-10bc-451d-e053-2995a90a5b37 | 2023-10-09 | Warnings | d9a75569-10bc-451d-e053-2995a90a5b37 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
