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
Phenylephrine hydrochloride 5 mg
Purpose
Pain reliever-fever reducer
Antihistamine
Nasal decongestant
Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
■ minor aches and pains
■ sore throat
■ headache
■ runny nose
■ sinus congestion and pressure
■ nasal congestion due to a cold or hay fever
■ runny nose
■ 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 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 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 whether a 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
Ask a doctor or pharmacist before use if the user is
■ taking tranquilizers or sedatives
■ taking the blood thinning drug warfarin
When using this product
■
do not exceed recommended dosage
■ may cause excitability especially in children
■ use caution when driving or operating machinery
■ avoid alcoholic beverages
■ may cause 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
■ fever gets worse or lasts more than 3 days
■ nasal congestion is accompanied by fever
■ nervousness, dizziness, or sleeplessness occur
■ redness or swelling is present
■ new symptoms occur
■ any of the following occurs (these could be signs of a serious condition):
■ severe sore throat
■ sore throat is accompanied or followed by fever, headache, rash, nausea or vomiting
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 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
colloidal silicon dioxide, corn starch, FD C yellow no. 6 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate
Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
■ you may also use this number to report serious adverse events associated with the use of this product
EXTRA FAST COLTALIN
Safely Sealed
NDC 51467-010-01
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes
24 Tablets
In Individually Sealed Strip
Aspirin Free
EXTRA FAST COLTALIN
Safely Sealed
NDC 51467-010-02
Acetaminophen - Pain Reliever-Fever Reducer
Chlorpheniramine maleate - Antihistamine
Phenylephrine hydrochloride - Nasal Decongestant
Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage
■ Sneezing, Runny Nose
■ Itchy, Watery Eyes
36 Tablets
In Individually Sealed Strip
Aspirin Free
| 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 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 51467-010 | 51467-010-01, 51467-010-02 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE K30 | U725QWY32X | IACT |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | 5856J3G2A2 | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 7 | 2025-11-13 | full-release | 2026-06-01 01:16:17 |
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 |
|---|---|---|---|---|---|---|
| 43811b3b-b4fe-6d6a-e063-6394a90a04a4 | ec1e59a0-bcad-49f0-b731-d15445d99370 | 2025-11-13 | Warnings | ec1e59a0-bcad-49f0-b731-d15445d99370 |
Adverse event summaries are temporarily unavailable. Other product information remains available.