COLTALIN-ND- acetaminophen, phenylephrine hydrochloride tablet

COLTALIN-ND by

Drug Labeling and Warnings

COLTALIN-ND by is a Otc medication manufactured, distributed, or labeled by FORTUNE PHARMACAL COMPANY LIMITED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

Purpose
Pain reliever-fever reducer
Nasal decongestant

INDICATIONS & USAGE

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

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

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.

ASK DOCTOR

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

ASK DOCTOR/PHARMACIST

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

WHEN USING

When using this product
■ do not exceed recommended dosage

STOP USE

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

WARNINGS

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

PREGNANCY OR BREAST FEEDING

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

KEEP OUT OF REACH OF CHILDREN

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

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

STORAGE AND HANDLING

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

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

COLTALIN-ND

Non-Drowsy

Safely Sealed

NDC: 51467-013-01

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

PRINCIPAL DISPLAY PANEL

COLTALIN-ND

Non-Drowsy

Safely Sealed

NDC: 51467-013-02

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

INGREDIENTS AND APPEARANCE

COLTALIN-ND 
acetaminophen, phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51467-013
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	SHIELDTM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51467-013-01	2 in 1 BOX	12/26/2024
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 51467-013-02	3 in 1 BOX	12/26/2024
2		12 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	part341	12/26/2024

Labeler - FORTUNE PHARMACAL COMPANY LIMITED (686280561)

Establishment
Name	Address	ID/FEI	Business Operations
FORTUNE PHARMACAL COMPANY LIMITED		686280561	manufacture(51467-013)