Drug Facts

Manufacturer
FORTUNE PHARMACAL COMPANY LIMITED
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-09-19 01:00:39

Label at a glance#

ProductCOLTALIN-ND
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients(in each tablet)
Acetaminophen 325 mg
Phenylephrine hydrochloride 5 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever-fever reducer
Nasal decongestant

INDICATIONS & USAGE SECTION

Uses
■ temporarily relieves these symptoms due to a cold, the flu, or hay fever:
   ■ minor aches and pains
   ■ sore throat
   ■ headache
   ■ sinus congestion and pressure
   ■ nasal congestion
■ temporarily reduces fever

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

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.
for fever for more than 3 days, unless directed by a physician
■ 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if the user has
■ heart disease
■ high blood pressure
■ diabetes
■ glaucoma
■ liver disease
■ thyroid disease
■ a high fever
■ difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user is
■ taking the blood thinning drug warfarin
■ taking a prescription drug and you do not know if it contains an MAOI

OTC - WHEN USING SECTION

When using this product
■ do not exceed recommended dosage

OTC - STOP USE SECTION

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 is severe
■ sore throat persists for more than 2 days
■ sore throat is accompanied or followed by:
   ■ fever
   ■ headache
   ■ rash
   ■ nausea
   ■ vomiting
■ nervousness, dizziness, or sleeplessness occur
■ fever gets worse or lasts more than 3 days
■ any of the following occurs (these could be signs of a serious condition):
   ■ new symptoms occur
   ■ pain or fever persist or gets worse
   ■ redness or swelling is present

Do not give to children under 6 years of age unless directed by a doctor.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information
■ keep tightly sealed
■ store between below 25 C (77 F) in a dry place, away from direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients
colloidal silicon dioxide, corn starch, FDC red no. 40 aluminum lake, magnesium stearate, povidone K30, sodium starch glycolate

OTC - QUESTIONS SECTION

Questions or comments?(888) 221-3496 M-F 9 am to 5 pm
■ you may also report serious side effects to this phone number

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLTALIN-ND

Non-Drowsy

Safely Sealed

NDC 51467-008-01

Acetaminophen - Pain Reliever-Fever Reducer
Phenylephrine Hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage

24 Tablets

In Individually Sealed Strip

Aspirin Free
IMAGE OF 24 TABLETS BOXIMAGE OF 24 TABLETS BOX

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLTALIN-ND

Non-Drowsy

Safely Sealed

NDC 51467-008-02

Acetaminophen - Pain Reliever-Fever Reducer
Phenylephrine Hydrochloride - Nasal Decongestant

Cold, Flu & Hay Fever Multi-Symptom Relief
■ Minor Aches & Pain, Sore Throat
■ Headache, Fever
■ Nasal Congestion, Sinus Pressure/Drainage

36 Tablets

In Individually Sealed Strip

Aspirin Free
IMAGE OF 36 TABLETS BOXIMAGE OF 36 TABLETS BOX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POVIDONE K30INACTIVE INGREDIENTU725QWY32X1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A21
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51467-00851467-008-01, 51467-008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-11-13full-release2026-06-01 01:16:01

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.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
COLLOIDAL SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / ORAL750 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43811fe7-01d2-6dae-e063-6394a90a24fc28f41696-7d67-436e-aa33-86d8ba82efd72025-11-13WarningsExact identifier
spl set id: 28f41696-7d67-436e-aa33-86d8ba82efd7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.