FACOL COLD AND FLU DAY AND NIGHT- acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue capsule, liquid filled

Facol Cold and Flu Day and Night by

Drug Labeling and Warnings

Facol Cold and Flu Day and 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 for DAY (In each capsule).......Purpose Active Ingredients for NIGHT (In each capsule).......Purpose

Acetaminophen 200mg............................pain reliever/fever reducer

Guaifenesin 35mg....................................expectorant

phenylephrine HCl 5mg............................nasal decongestant

dextromethorphan Hbr8mg.......................cough suppressant

Acetaminophen 200mg............................pain reliever/fever reducer

Guaifenesin 35mg....................................expectorant

phenylephrine HCl 5mg............................nasal decongestant

dextromethorphan Hbr8mg.......................cough suppressant

Diphenhyddramine Hydrochloride 18.75mg......antihistamine

Uses

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

Do not use

■ in children under 12 years of age
■ 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) 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 drink when taking doses ■Do not exceed recommended dose
■ be careful when driving motor vehicle (nighttime capsule)

Stop use and ask a doctor if

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).

OtherInformation

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

Inactive Ingredients

Questions or Comments?

1-562-281-5888 Monday-Friday 9AM-4PM EST
Distributed by: Jemian USA Inc.

Directions

■ Do not take more than directed

■ children under 15 years: ask a doctor
■ adults and children 15 years and over: take 2 daytime capsules 2 times a day
■ Take 2 nighttime capsules before sleep
■ do not take nighttime capsule and daytime capsule together

INDICATIONS & USAGE

temporarily relieves common cold and flu symptoms and minor aches

PRINCIPAL DISPLAY PANEL

NDC: 69365-004-01

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DO NOT TAKE DAY CAPSULE AND NIGHT CAPSULE TOGETHER

Facol Cold & Flu Day & Night

MULTI

Soft liquid filled capsule

Guaifenesin-expectorant

Acetaminophen-Fever/pain reliever

Phenylephrine HCl-Nasal Decongestant

Dextromethorphan HBr- Cough Suppressant

Diphenhydramine HCl-antihistamine (night time capsule only)

non drowsy Day

sleep aid Night

10 capsulesJW Pharmaceuticals

INGREDIENTS AND APPEARANCE

FACOL COLD AND FLU DAY AND NIGHT 
acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac color, gardenia blue capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69365-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	18.75 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	8 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	35 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	200 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)	206.22 mg
POVIDONE K29/32 (UNII: 390RMW2PEQ)	33 mg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	40 mg
WATER (UNII: 059QF0KO0R)	70.4 mg
SORBITOL (UNII: 506T60A25R)	142.88 mg
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)	440.25 mg
ALUMINUM OXIDE (UNII: LMI26O6933)	2.185 mg
COCHINEAL (UNII: TZ8Z31B35M)	2.185 mg
GARDENIAN BLUE (UNII: 54A6568109)	0.49

Product Characteristics
Color	yellow (soft liquid filled capsule) , blue (soft liquid filled capsule)	Score	no score
Shape	CAPSULE (rounded liquid filled cap)	Size	20mm
Flavor		Imprint Code	FDFN
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69365-004-01	1 in 1 CARTON	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(69365-004) , pack(69365-004) , label(69365-004) , sterilize(69365-004) , analysis(69365-004)