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Facol Cold and Flu Day and Night

Medically reviewed by Drugs.com. Last updated on Nov 29, 2018.

Dosage form: capsule, liquid filled
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 18.75mg, DEXTROMETHORPHAN HYDROBROMIDE 8mg, PHENYLEPHRINE HYDROCHLORIDE 5mg, GUAIFENESIN 35mg, ACETAMINOPHEN 200mg
Labeler: JW HOLDINGS
NDC Code: 69365-004

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

FACOL COLD AND FLU DAY AND NIGHT

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

temporarily relieves common cold and flu symptoms and minor aches

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-004
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE18.75 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE8 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN35 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN200 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN206.22 mg
POVIDONE K29/3233 mg
PROPYLENE GLYCOL40 mg
WATER70.4 mg
SORBITOL142.88 mg
POLYETHYLENE GLYCOL 400440.25 mg
ALUMINUM OXIDE2.185 mg
COCHINEAL2.185 mg
GARDENIAN BLUE0.49 
Product Characteristics
Coloryellow (soft liquid filled capsule) , blue (soft liquid filled capsule) Scoreno score
ShapeCAPSULE (rounded liquid filled cap) Size20mm
FlavorImprint CodeFDFN
Contains    
Packaging
#Item CodePackage Description
1NDC:69365-004-011 BLISTER PACK in 1 CARTON
11 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/01/2015
Labeler - JW HOLDINGS (631094492)
Registrant - JW HOLDINGS (631094492)
Establishment
NameAddressID/FEIOperations
RP Bio Inc.689851235manufacture(69365-004), pack(69365-004), label(69365-004), sterilize(69365-004), analysis(69365-004)

 
JW HOLDINGS

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