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
Purpose
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
Allergy alert:Acetaminophen may cause severe skin reactions.
If a skin rash occurs, stop use and seek medical help right away.
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
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 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 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 ingredients
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 51467-012-01
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 51467-012-02
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
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51467-012 | 51467-012-01, 51467-012-02 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 3 | 2026-02-13 | full-release | 2026-06-01 01:45:54 |
| 2 | 2025-11-13 | monthly-update | 2026-06-03 17:40:11 |
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 |
|---|---|---|---|---|---|---|
| COLTALIN-DM | ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | FORTUNE PHARMACAL COMPANY LIMITED | 33e1bec0-323b-40b7-809a-cb65a71ad0ce | 2026-09-17 | Warnings | 51467-012-02 51467-012-01 51467-012 51467001202 51467001201 5bb2b1bb-0b8f-02a6-e063-6294a90a0763 33e1bec0-323b-40b7-809a-cb65a71ad0ce |
Adverse event summaries are temporarily unavailable. Other product information remains available.