AP SAFE Chest Congestion & Cough Relief DM
- Manufacturer
- AptaPharma Inc.
- Effective date
- 2026-05-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 01:56:42
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
Active ingredients
(per Softgel)
Dextromethorphan HBr ....10 mg
Guaifenesin ..................200 mg
OTC - PURPOSE SECTION
Purposes
Dextromethorphan HBr ....Cough Suppressant
Guaifenesin ....................Expectorant
INDICATIONS & USAGE SECTION
Uses
• helps loosen phlegm (mucus) and thin bronchial
secretions to make cough more productive
• temporarily relieves cough due to minor throat
and bronchial irritation as may occur with a cold
WARNINGS SECTION
Warnings
OTC - DO NOT USE SECTION
Do not use 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 two 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.
OTC - ASK DOCTOR SECTION
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.
OTC - STOP USE SECTION
Stop use and ask a doctor if
• cough lasts for more than 7 days, comes back, or is accompanied by
fever, rash or persistent headache. These couid 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 12 softgels in any 24-hour period
• This product is not intended for use in children under 12 years
• Adults & children 12 years and over - 2 softgels every 4 hours
• Children under 12 years of age - do not use
OTHER SAFETY INFORMATION
Other information
• Store at room temperature
• Avoid excessive heat above 40°C (104°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C Red #40, Gelatin, glycerin, Polyethylene glycol, Povidone, Propylene glycol, purified water,
Sorbitol sorbitan solution, Titanium dioxide
OTC - QUESTIONS SECTION
Questions?1-877-798-5944
Product Label: AP SAFE Chest Congestion & Cough Relief DM
------------------------------------------------------
AP SAFE® Chest Congestion *Compare to the active ingredients
& Cough Relief DM In Robitussin®Maximum Strength
Cough & Chest Congestion DM
Dextromethorphan HBr - Cough suppressant
Guaifenesin - Expectorant
Ages 12+
20 Softgels
Manufactured by AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 08110
• This product is not manufactured or distributed by Pfizer Consumer Healthcare,
distributors of Robitussin® Maximum Strength Cough & Chest Congestion DM
TAMPER EVIDENT:DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN,
BROKEN OR SHOWS ANY SIGNS OF TAMPERING
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
res
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| DEXTROMETHORPHAN Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| GUAIFENESIN Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20211129 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| bf324df6-7127-7deb-def5-2681c136cd03 | Product name | 3 | 20250325 |
| 43a1ed49-eae2-4840-8075-cb4b33478540 | Product name | 1 | 20230425 |
| ba088a92-ab5e-b2d4-e908-f5ea691b7587 | Product name | 7 | 20210201 |
| 4fe95224-f543-4dbb-9445-8cca122b48c8 | Product name | 1 | 20150609 |
| e8718272-64cb-4436-969b-176c3067c8f4 | Product name | 1 | 20150609 |
| 106ff02a-57e1-4c4c-a307-fd582ff4e311 | Product name | 1 | 20150212 |
| 76633df9-0d59-4b88-03ed-21dee1b966f8 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 76281-601-02 | Maximum Strength Tussin DM Liquid filled Softgels | 10 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 10 | 1 | |
| 76281-601-02 | Maximum Strength Tussin DM Liquid filled Softgels | 2 in 1 CARTON | CAPSULE, LIQUID FILLED | 2 | 1 |
Products#
Every source-derived product name is available through these pages.
- Maximum Strength Tussin DM Liquid filled Softgels
- DEXTROMETHORPHAN HBr, GUAIFENESIN
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- GUAIFENESIN
- FD&C RED NO. 40
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL, UNSPECIFIED
- POVIDONE
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 76281-601 | 76281-601-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| GUAIFENESIN | 495W7451VQ | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| POVIDONE | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| Maximum Strength Tussin DM Liquid filled Softgels | DEXTROMETHORPHAN HBR, GUAIFENESIN | AptaPharma Inc. | 39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1 | 2026-05-10 | Warnings | 76281-601-02 76281-601 76281060102 e2f34ff2-7880-4bdf-9193-5873515400f3 39ad6cc9-d2b0-4b4a-8aa3-977905c9e6f1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
