Indications and uses
• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold • temporarily relieves runny nose and sneezing due to the common cold
Cough and Cold
- Manufacturer
- Proficient Rx LP
- Effective date
- 2018-12-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 22:58:16
Label at a glance#
ProductCough and Cold
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE
Label structure9 sections
Dosage and administration
• do not exceed recommended dose • adults and children 12 years and over: 1 tablet every 6 hours. Do not take more than 4 tablets in 24 hours • children under 12 years: do not use
Storage and handling
• TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN • store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) • see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each tablet)
Chlorpheniramine maleate 4 mg
Dextromethorphan HBr 30 mg
Purpose
Antihistamine
Cough suppressant
Uses
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- temporarily relieves runny nose and sneezing due to the common cold
Warnings
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 2 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.
Ask a doctor before use if you have
- trouble urinating due to an enlarged prostate gland
- glaucoma
- cough that occurs with excessive phlegm (mucus)
- a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.
When using this product
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- alcohol, sedatives, and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
persistent cough lasts for more than one week, tends to recur, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- do not exceed recommended dose
- adults and children 12 years and over: 1 tablet every 6 hours. Do not take more than 4 tablets in 24 hours
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- see end flap for expiration date and lot number
Inactive ingredients
acacia, black iron oxide, calcium carbonate, carnauba was, croscarmellose sodium, D&C red #27 aluminum lake, FD&C yellow #6 aluminum lake, lactose, magnesium stearate, methylparaben, microcrystalline cellulose, povidone, propylparaben, propylene glycol, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide
Questions or comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 63187-689-16
*Compare to the active ingredients in Coricidin® HBP Cough & Cold
Cough & Cold
Relief for people with High Blood Pressure
Chlorpheniramine maleate - Antihistamine
Dextromethorphan HBr - Cough Suppressant
Decongestant Free
Relieves
• Cough • Runny Nose • Sneezing
16 TABLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by MSD Consumer Care, Inc., owner of the registered trademark Coricidin® HBP Cough & Cold.
50844 REV0714D41121
Distributed by MAJOR® PHARMACEUTICALS
31778 Enterprise Drive, Livonia, MI 48150 USA M-17
Re-order No. 873602 Rev. 08/14
Relabeled By: Proficient Rx LP
Thousand Oaks, CA 91320
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d17a97fa-387f-690e-d2be-0083ab044a03 | Product name | 3 | 20170725 |
| 0fdb98e2-b951-a1ce-5715-2b187ba500ef | Product name | 4 | 20170718 |
| c6fba691-a132-4ede-95c6-f8c6bd696636 | Product name | 1 | 20150902 |
| c0200ab5-4954-454e-9676-30b741b245bd | Product name | 1 | 20150730 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 63187-689-16 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-4d0c-a910-e053-dadaa90a0b85 | Major 44-411 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-5817-44 | EA - Each | 0904-5817 | d699fd90-77bf-47da-a6ef-8291163c787c | 1 | 2013-08-02 |
Products#
Every source-derived product name is available through these pages.
- Cough and Cold
- Chlorpheniramine maleate, Dextromethorphan HBr
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- DEXTROMETHORPHAN HYDROBROMIDE
- DEXTROMETHORPHAN
- ACACIA
- CALCIUM CARBONATE
- CARNAUBA WAX
- CROSCARMELLOSE SODIUM
- D&C RED NO. 27
- MAGNESIUM STEARATE
- METHYLPARABEN
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- PROPYLPARABEN
- PROPYLENE GLYCOL
- SHELLAC
- SODIUM BENZOATE
- STEARIC ACID
- TALC
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 63187-689 | 63187-689-16 |
| 0904-5817 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| 1fdbe523-a10e-4808-9c65-0a0cf4119293 | bc293912-9ae2-459d-9ac5-2bad046f7e1a | 2025-10-01 | Warnings | bc293912-9ae2-459d-9ac5-2bad046f7e1a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.