FACOL COLD AND FLU NIGHT- acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl capsule, liquid filled

Facol Cold and Flu Night by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients (in each tablet) Purpose

Acetaminophen 200mg ………………………………………………………….………………pain reliever /fever reducer
Guaifenesin 35mg…………………………………………………………………………….……...expectorant
Phenylephrine HCl 5mg……………………….……………………………………………....….nasal decongestant

Dextromethorphan HBr 8mg…………………………………………………cough suppression
Diphenhydramine HCl 15mg………………………………………………..antihistamine

Inactive Ingredients

purified water, polyethylene glycol 400, propylene glycol, gelatin, povidone, sorbitol, gardenia blue

Uses

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 caplets in 24 hours. Severe liver damage may occur if you take
■ more than 4,000 mg of acetaminophen in 24 hours
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product

INDICATIONS & USAGE

Relief cold symptoms and minor pains.

Directions

■ adults and children 15 years and older: take 2 capsules after a meal 2 times a day ■ Do not take more than directed
■ children under 15 years: do not use and ask a doctor.

Ask a doctor before usei if

you have ■ allergic reaction ■ asthma ■ liver disease ■ pregnant or breast feeding ■ medical care ■ glaucoma ■ high blood pressure ■ thyroid disease ■ heart disease ■ diabetes

Ask a doctor or pharmacist before use if you

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

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)

Keep out of reach of children.

If pregnant or breast-feeding

Do not take this drug and ask a health professional

Questions or Comments?

Call 1-562-281-5888 Monday - Friday 9AM-4PM Est

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.

When using this product

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

■ Avoid drive or use of machineries.

Other Information

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).

PRINCIPAL DISPLAY PANEL

NDC: 69365-003-01

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Facol Cold & Flu Night

MULTI

Soft liquid filled capsule

Guaifenesin-Expectorant

Acetaminophen-Fever/pain reliever

Phenylephrine HCl-Nasal Decongestant

Dextromethorphan HBr- Cough Suppressant

Diphenhydramine HCl-Antihistamine

sleep aid

10 capsules

JW Pharmaceuticals

INGREDIENTS AND APPEARANCE

FACOL COLD AND FLU NIGHT 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69365-003
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
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	8 mg
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	18.75 mg

Inactive Ingredients
Ingredient Name	Strength
GARDENIAN BLUE (UNII: 54A6568109)	0.49 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	440.25 mg
WATER (UNII: 059QF0KO0R)	70.4 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	40 mg
POVIDONE K29/32 (UNII: 390RMW2PEQ)	33 mg
GELATIN (UNII: 2G86QN327L)	206.22 mg
SORBITOL (UNII: 506T60A25R)	142.88 mg

Product Characteristics
Color	blue (Light bluish liquid filled soft gel)	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code	FacN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69365-003-02	1 in 1 CARTON	08/01/2015
1		1 in 1 BLISTER PACK
1		10 in 1 CAPSULE; 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(69365-003) , pack(69365-003) , analysis(69365-003) , label(69365-003) , sterilize(69365-003)