Storage and handling
Other information ■ keep tightly sealed ■ store between below 25 C (77 F) in a dry place, away from direct sunlight
Other information ■ keep tightly sealed ■ store between below 25 C (77 F) in a dry place, away from direct sunlight
Active ingredients (in each tablet)
Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine hydrochloride 5 mg
Purposes
Pain reliever-fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
■ minor aches and pains
■ headache
■ sore throat
■ nasal congestion
■ runny nose
■ sinus congestion and pressure
■ cough due to minor throat and bronchial irritation
■ sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
■ temporarily reduces fever
■ promotes nasal and/or sinus drainage
Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if
■ adult takes more than 12 tablets in 24 hours, which is the maximum daily amount for this product
■ child takes more than 5 doses in 24 hours
■ taken with other drugs containing acetaminophen
■ adult has 3 or more alcoholic drinks everyday while using this product
Do not use
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
■ if the user is 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 the user has
■ heart disease
■ high blood pressure
■ diabetes
■ glaucoma
■ liver disease
■ thyroid disease
■ a high fever
■ a breathing problem such as emphysema or chronic bronchitis
■ difficulty in urination due to enlargement of the prostate gland
■ a persistent cough
Ask a doctor or pharmacist before use if the user is
■ taking sedatives or tranquilizers
■ taking the blood thinning drug warfarin
When using this product
■ do not exceed recommended dosage
■ may cause excitability especially in children
■ do not drive or operate machinery
■ avoid alcoholic beverages
■ may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
Stop use and ask a doctor if
■ pain or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
■ sore throat persists for more than 2 days
■ nasal congestion is accompanied by fever
■ nervousness, dizziness, or sleeplessness occur
■ any of the following occurs (these could be signs of a serious condition):
■ fever gets worse or lasts more than 3 days
■ a severe sore throat
■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting
■ redness or swelling is present
■ new symptoms occur
■ cough persists for more than 1 week, tends to recur, or is accompanied by fever rash, or persistent headache
Do not give to children under 6 years of age unless directed by a doctor.
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 right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
■ adults and children 12 years of age and over: 2 tablets every 4 hours, while symptoms persist, not to exceed 6 doses (12 tablets) in 24 hours, or as directed by a doctor
■ children 6 to under 12 years of age: 1 tablet every 4 hours, while symptoms persist, not to exceed 5 doses (5 tablets) in 24 hours, or as directed by a doctor
■ children under 6 of age : consult a doctor
Other information
■ keep tightly sealed
■ store between below 25 C (77 F) in a dry place, away from direct sunlight
Inactive ingredient
Citric Acid Monohydrate, Hydroxypropyl Methylcellulose, Corn starch, Microcrystalline Cellulose, D&C Yellow No.10 Aluminum Lake, Colloidal silicon dioxide, Magnesium stearate, Sodium Starch Glycolate.
Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number
COLTALIN-DM
Safely Sealed
NDC 51467-007-01
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan Hydrobromide - Cough Suppressant
Phenylephrine Hydrochloride - Nasal Decongestant
Cough, Cold & Flu Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Cough
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes
24 Tablets
In Individually Sealed Strip
Aspirin Free
COLTALIN-DM
Safely Sealed
NDC 51467-007-02
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine Maleate - Antihistamine
Dextromethorphan Hydrobromide - Cough Suppressant
Phenylephrine Hydrochloride - Nasal Decongestant
Cough, Cold & Flu Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Cough
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes
36 Tablets
In Individually Sealed Strip
Aspirin Free
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE MALEATE | ACTIVE INGREDIENT | V1Q0O9OJ9Z | 1 | |
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | 1 | |
| PHENYLEPHRINE HYDROCHLORIDE | ACTIVE INGREDIENT | 04JA59TNSJ | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| CHLORPHENIRAMINE | ACTIVE MOIETY | 3U6IO1965U | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | 1 | |
| PHENYLEPHRINE | ACTIVE MOIETY | 1WS297W6MV | 1 | |
| COLLOIDAL SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POVIDONE K30 | INACTIVE INGREDIENT | U725QWY32X | 1 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51467-007 | 51467-007-01, 51467-007-02 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 10 | 2026-02-13 | full-release | 2026-06-01 01:44:20 |
| 8 | 2025-11-13 | monthly-update | 2026-06-03 17:40:10 |
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 |
|---|---|---|---|---|---|---|
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| COLLOIDAL SILICON DIOXIDE | SILICON DIOXIDE | ETJ7Z6XBU4 | TABLET / ORAL | 750 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET / ORAL | 980 mg | ||
| POVIDONE K30 | POVIDONE K30 | U725QWY32X | TABLET / ORAL | 2828 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| D&C YELLOW NO. 10 | D&C YELLOW NO. 10 | 35SW5USQ3G | TABLET / ORAL | 80 mg |
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 |
|---|---|---|---|---|---|---|
| 4abdf7dc-664a-a821-e063-6294a90aa868 | 8b1138f2-aad0-43ef-80d4-e36f92fe5e93 | 2026-02-13 | Warnings | 8b1138f2-aad0-43ef-80d4-e36f92fe5e93 |
Adverse event summaries are temporarily unavailable. Other product information remains available.