Adult Tussin Expectorant
- Manufacturer
- Chain Drug Marketing Association, Inc. | AptaPharma, Inc.
- Effective date
- 2023-12-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:16:30
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients
(in each 5 mL teaspoon)
Guaifenesin, USP 100 mg
OTC - PURPOSE SECTION
Purpose
Expectorant
INDICATIONS & USAGE SECTION
Uses
■ Helps loosen phlegm (mucus) and thin bronchial
secretions to rid the bronchial passageways of
bothersome mucus and make coughs more
productive
WARNINGS SECTION
Warnings
Ask a doctor before use if you have
■ cough that occurs with too much phlegm (mucus)
■ cough that lasts or is chronic such as occurs with
smoking, asthma, chronic bronchitis, or
emphysema
When using this product
■ do not use more than directed
Stop use and ask a doctor if
■ cough lasts more than 7 days, comes back, or
occurs with fever, rash, or persistent headache.
These could be signs of a serious condition.
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 overdose,
get medical help or contact a Poison Control center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
■ do not take more than 6 doses in any 24-hour period
| Adults and children 12 years and over | 2-4 teaspoonfuls every 4 hours |
| Children under 12 years | do not use |
OTHER SAFETY INFORMATION
Other information
■ each 5 mL contains: sodium 3 mg
■ store between 20-25 ° C (68-77° F)
■ do not refrigerate
■ dosing cup provided
■ Keep carton for full directions for use
INACTIVE INGREDIENT SECTION
Inactive ingredients
Caramel, citric acid anhydrous, dextrose, FD&C red
#40, flavor, glycerin, high fructose corn syrup,
menthol, purified water, saccharin sodium, sodium
benzoate
OTC - QUESTIONS SECTION
Questions? Call weekdays from 9:30AM to 4:30
PM EST at 1-877-798-5944
Product Label
Adult NDC 63868-039-04
Tussin
Expectorant
Guaifenesin
Oral Solution, USP
For Ages 12 & Over
Non-Drowsy
• Relieves Chest
Congestion
• Loosens Mucus
• For ages 12 & Over
4 fl oz (118 mL)
*This product is not manufactured or distributed by
Pfizer, the distributor of Robitussin® Mucus plus
Chest Congestion.
Manufactured by:
AptaPharma Inc.,
1533 Union Ave.
Pennsauken, NJ 08110
Distributed by CDMA., Inc.
43157 W 9Nine Mile
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
res
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63868-039-04 | ML - Milliliter | 63868-039 | fa4010b9-6112-4afc-9840-63ef52856e14 | 1 | 2022-09-12 |
Products#
Every source-derived product name is available through these pages.
- Adult Tussin Expectorant
- GUAIFENESIN
- CARAMEL
- ANHYDROUS CITRIC ACID
- DEXTROSE
- FD&C RED NO. 40
- GLYCERIN
- HIGH FRUCTOSE CORN SYRUP
- MENTHOL
- WATER
- SACCHARIN SODIUM
- SODIUM BENZOATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63868-039 | 63868-039-04 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GUAIFENESIN | 495W7451VQ | ACTIB |
| CARAMEL | T9D99G2B1R | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| DEXTROSE | IY9XDZ35W2 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| MENTHOL | L7T10EIP3A | IACT |
| WATER | 059QF0KO0R | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SODIUM BENZOATE | OJ245FE5EU | 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 |
|---|---|---|---|---|---|---|
| 3ac8c0a1-6080-4326-b5c6-312c552d5002 | c73dbb97-5f08-4b19-8961-4304f64c3173 | 2024-12-23 | Warnings | c73dbb97-5f08-4b19-8961-4304f64c3173 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.

