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
- Major Pharmaceuticals | LNK International, Inc.
- Effective date
- 2019-06-24
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 10
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:20:31
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, propylene glycol, propylparaben, shellac, silica gel, sodium benzoate, stearic acid, sugar, talc, titanium dioxide
Questions or comments?
(800) 616-2471
Principal Display Panel
MAJOR®
NDC 0904-5817-44
*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
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 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 5 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 5 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 5 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 5 | |
| ACACIA | INACTIVE INGREDIENT | 5C5403N26O | 5 | |
| CALCIUM CARBONATE | INACTIVE INGREDIENT | H0G9379FGK | 5 | |
| CARNAUBA WAX | INACTIVE INGREDIENT | R12CBM0EIZ | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | 5 | |
| D&C RED NO. 27 | INACTIVE INGREDIENT | 2LRS185U6K | 5 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 5 | |
| POVIDONES | INACTIVE INGREDIENT | FZ989GH94E | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 5 | |
| SHELLAC | INACTIVE INGREDIENT | 46N107B71O | 5 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | 5 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 5 | |
| TALC | INACTIVE INGREDIENT | 7SEV7J4R1U | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | 5 |
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
- FERROSOFERRIC OXIDE
- FD&C YELLOW NO. 6
- LACTOSE, UNSPECIFIED FORM
- SILICON DIOXIDE
- SUCROSE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0904-5817 | 0904-5817-44 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SHAMPOO / TOPICAL | 8 %w/w | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / TOPICAL | 0.1 %w/v | ||
| TALC | TALC | 7SEV7J4R1U | CAPSULE, DELAYED RELEASE / ORAL | 420 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | AEROSOL, FOAM / TOPICAL | 0.04 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, ORALLY DISINTEGRATING / ORAL | 10 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | POWDER / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| TALC | TALC | 7SEV7J4R1U | GUM, CHEWING / BUCCAL | NA | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, DELAYED RELEASE / ORAL | 1060 mg | ||
| ACACIA | ACACIA | 5C5403N26O | TABLET, DELAYED RELEASE / ORAL | 30 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| TALC | TALC | 7SEV7J4R1U | DROPS / ORAL | NA | ||
| CALCIUM CARBONATE | CALCIUM CARBONATE | H0G9379FGK | TABLET, DELAYED RELEASE / ORAL | 8.4 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | AEROSOL, FOAM / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, EXTENDED RELEASE / TRANSDERMAL | 58.13 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION, EXTENDED RELEASE / ORAL | 1000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | PELLET / ORAL | 24 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SWAB / TOPICAL | 34.6 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | LOTION / TOPICAL | 80 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / IRRIGATION | 2 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / RESPIRATORY (INHALATION) | 25 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | TABLET, CHEWABLE / ORAL | 0.14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, DELAYED RELEASE PELLETS / ORAL | 32 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | SUSPENSION / ORAL | 150 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | CAPSULE, EXTENDED RELEASE / ORAL | 67 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / PERINEURAL | 80 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | GRANULE, FOR SUSPENSION / ORAL | 80 mg | ||
| CARNAUBA WAX | CARNAUBA WAX | R12CBM0EIZ | CAPSULE, EXTENDED RELEASE / ORAL | 288 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | PASTE / DENTAL | 0.5 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM / VAGINAL | 3 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SHAMPOO / TOPICAL | 0.15 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION/ DROPS / OPHTHALMIC | 0.01 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | 15 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / TRANSMUCOSAL | 100 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT, AUGMENTED / TOPICAL | 714 mg | ||
| TALC | TALC | 7SEV7J4R1U | TABLET, FOR SUSPENSION / ORAL | 24 mg | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 42 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | CAPSULE, COATED PELLETS / ORAL | 198 mg | ||
| CROSCARMELLOSE SODIUM | CROSCARMELLOSE SODIUM | M28OL1HH48 | INJECTION / INTRAMUSCULAR | 1 %w/v | ||
| TITANIUM DIOXIDE | TITANIUM DIOXIDE | 15FIX9V2JP | TABLET, EXTENDED RELEASE / ORAL | 90 mg | ||
| SODIUM BENZOATE | SODIUM BENZOATE | OJ245FE5EU | SOLUTION / ORAL | 660 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER / ORAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | EMULSION / TOPICAL | 0.2 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRA-ARTICULAR | 0.03 %w/v | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| POVIDONES | POVIDONE | FZ989GH94E | TABLET / SUBLINGUAL | 6 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INFILTRATION | 80 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | JELLY / NASAL | 140 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / TOPICAL | 5.28 %w/v |
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 |
|---|---|---|---|---|---|---|
| 7ede4f64-d5c5-4743-97b8-81b8ab4abf4d | 7a025ad8-d269-4125-ae32-35178dca897a | 2019-06-24 | Warnings | 7ede4f64-d5c5-4743-97b8-81b8ab4abf4d 7a025ad8-d269-4125-ae32-35178dca897a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.