Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg
OTC - PURPOSE SECTION
Purpose Cough Suppressant Expectorant
Leader Chest Congestion Relief
- Manufacturer
- Cardinal Health | Reese Pharmaceutical Co | Pharbest
- Effective date
- 2024-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:44:45
Key Label Information#
Uses
Uses
■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■ Helps make coughs more productive.
Warnings
Warnings
Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
Directions And Dosage
DOSAGE & ADMINISTRATION SECTION
Directions ■ Adults and children 12 years of age and over : take 1 tablet every 4 hours as needed. ■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed. ■ Children under 6 years of age: consult a doctor. Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other Label Information
Other Information
Store at 15°-30°C (59°-86°F)
INACTIVE INGREDIENT SECTION
Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.
Label Images#
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 |
|---|---|---|---|---|---|---|
| 70000-0056-1 | Leader Chest Congestion ReliefDM | 60 in 1 BOTTLE | TABLET | 60 | 5 | |
| 70000-0056-1 | Leader Chest Congestion ReliefDM | 1 in 1 CARTON | TABLET | 1 | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0056 | LEADER CHEST CONGESTION RELIEF DM (DEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESIN) TABLET [CARDINAL HEALTH] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241220_8397e1b9-e83e-4c6a-b858-1663c2365840.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70000-0056-1 | EA - Each | 70000-0056 | fe576597-ff51-4f4f-9596-7a3c3c1add68 | 1 | 2021-11-09 |
Products#
- Leader Chest Congestion Relief DM
- Dextromethorphan Hydrobromide / Guaifenesin
- DEXTROMETHORPHAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0056 | 70000-0056-1 |
Ingredients#
| Name | UNII | Kind |
|---|---|---|
| DEXTROMETHORPHAN HYDROBROMIDE | 9D2RTI9KYH | ACTIB |
| Guaifenesin | 495W7451VQ | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| MALTODEXTRIN | 7CVR7L4A2D | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Complete SPL Sections#
OTC - ACTIVE INGREDIENT SECTION
Active ingredient - (per tablet) Dextromethorphan Hydrobromide 20mg Guaifenesin 400mg
OTC - PURPOSE SECTION
Purpose Cough Suppressant Expectorant
Uses
■ Temporarily relieves cough due to minor throat and bronchial irritation as may occur with a common cold ■ Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus ■ Helps make coughs more productive.
Warnings
Do not use ■ if you are now taking a prescription monoamine oxidase (inhiMor~MAIO) (Certain drugs for depression, psychiatric or emotional conditioners or Parkinson's disease)or for 2 weeks after stopping MAIO drug, If you do not know if your prescription drug contains an MAIO, ask your doctor or pharmacist before using this product.
OTC - ASK DOCTOR SECTION
Ask doctor before use if you have ■ persistent or chronic cough, such as occurs with smoking, asthma, bronchitis or emphysma ■ cough is accompanied by excessive phlegm (mucus)
OTC - STOP USE SECTION
Stop use and ask doctor if ■ symptoms are accompanied by fever, rash or persistent headache ■ cough persists for more than 1 week or tends to recur. A persistent cough may be a sign 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 Center immediately.
DOSAGE & ADMINISTRATION SECTION
Directions ■ Adults and children 12 years of age and over : take 1 tablet every 4 hours as needed. ■ Children 6 to 10 under 12 years of age: take 1/2 tablet every 4 hours as needed. ■ Children under 6 years of age: consult a doctor. Do not exceed 6 doses in a 24 hour period or as directed by a doctor
Other Information
Store at 15°-30°C (59°-86°F)
INACTIVE INGREDIENT SECTION
Inactive Ingredients magnesium stearate, microcrystalline cellulose. May also contain (colloidal) silicon dioxide, (co) povidone, dicalcium phosphate, maltodextrin, sodium starch glycolate, stearic acid.