FACOL COLD AND FLU DAY- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled

Facol Cold and Flu Day by

Drug Labeling and Warnings

Facol Cold and Flu Day by is a Otc medication manufactured, distributed, or labeled by JW Holdings, RP Bio Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Do not use

■ For children who are younger than 3 months old. (new born baby)
■ If you ever had an allergic reaction to this product or any of its ingredients.
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or a pharmacist)

Ask a doctor before use if you have

■ liver disease
■ asthma, chronic bronchitis or emphysema
■ thyroid disease
■ heart disease

■ diabetes

■ glaucoma

■ high blood pressure

Ask a doctor or pharmacist before use if you are

■ taking sedatives or tranquilizers ■ having chicken fox or other infections
■ taking the blood thinning drug warfarin

When using this product

■ Do not exceed recommended dose
■ Do not drink when taking doses

Stop use and ask a doctor if

■ nervousness, dizziness, or sleeplessness, constipation occurs
■ redness or swelling is present ■ fever get worse or lasts more than 3 days
■ new severe symptoms occur such as shock (anaphylaxis), Stevens Johnson Syndrome, Lyell Syndrome, Asthma, Dyshepatia or Interstitial lung diseases.
■ pain, cough, nasal congestion gets worse or lasts after 5-6 times of taking a dose.

If Pregnant or breast-feeding

do not take this drug and ask a health professional

Keep out of reach of children.

Overdose warning:

Do not exceed recommended dose. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-333-2333).

Uses

■ temporary relief of the following cold symptoms.
■ sore throat ■ minor aches and pains ■ headache ■ fever
■ nasal congestion ■ sinus congestion and pressure ■ cough

Other Information

■ Store between room temperature 20-25°C (68-77°F)
■ Avoid direct light or humid condition and excessive heat

Questions or Comments?

1-562-281-5888 Monday-Friday 9AM-4PM EST

Distributed by: Jemian USA Inc.

Inactive Ingredients

purified water, polyethylene glycol 400, propylene glycol, povidone, gelatin, sorbitol, purified water, lac color

Warnings

Directions

■ Do not take more than directed (see overdose warning)
■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day
■ swallow whole-do not crush, chew or dissolve
■ do not take night time capsule in less than 6 hours after taking day time capsule
■ children under 15 years: do not use and ask a doctor.

INDICATIONS & USAGE

Relief mild to moderately severe pain, Temporarily reduce multi cold symptom

Active Ingredient(in each tablet) Purpose

Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
Guaifenesin 35mg…………………………………………………………………………….……...expectorant

Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant
Dextromethorphan HBr 8mg…………………………………………………cough suppression

PRINCILA DISPLAY PANEL

NDC: 69365-001-01

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

MULTI

Facol® Cold and Flu

soft liquid filled capsule

DAY

Guaifenesin-Expectorant

Acetaminophen-Fever/Pain Reducer

Phenylephrine HCl-Nasal Decongestant

Dextromethorphan HBr-Cough Suppressant

10 capsules

JW pharmaceuticals

INGREDIENTS AND APPEARANCE

FACOL COLD AND FLU DAY 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69365-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	35 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	40 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	459 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	40 mg
GELATIN (UNII: 2G86QN327L)	203.93 mg
POVIDONE K29/32 (UNII: 390RMW2PEQ)	33 mg
SORBITOL (UNII: 506T60A25R)	141.1 mg
COCHINEAL (UNII: TZ8Z31B35M)	2.185 mg
ALUMINUM OXIDE (UNII: LMI26O6933)	2.185 mg

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	FacD
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69365-001-02	1 in 1 KIT	08/01/2015
1		1 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 not final	part343	08/01/2015

Labeler - JW Holdings (631094492)

Registrant - JW Holdings (631094492)

Establishment
Name	Address	ID/FEI	Business Operations
RP Bio Inc.		689851235	manufacture(69365-001) , pack(69365-001) , analysis(69365-001) , label(69365-001)