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Facol Cold and Flu Day

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

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 200mg, GUAIFENESIN 35mg, DEXTROMETHORPHAN HYDROBROMIDE 8mg, PHENYLEPHRINE HYDROCHLORIDE 5mg
Labeler: JW Holdings
NDC Code: 69365-001

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

FACOL COLD AND FLU DAY

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

FACOL COLD AND FLU DAY 
acetaminophen, guaifenesin, phenylephrine hcl, dextromethorphan hydrobromide capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69365-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN200 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN35 mg
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE8 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
WATER40 mg
POLYETHYLENE GLYCOL 400459 mg
PROPYLENE GLYCOL40 mg
GELATIN203.93 mg
POVIDONE K29/3233 mg
SORBITOL141.1 mg
COCHINEAL2.185 mg
ALUMINUM OXIDE2.185 mg
Product Characteristics
ColoryellowScoreno score
ShapeCAPSULESize20mm
FlavorImprint CodeFacD
Contains    
Packaging
#Item CodePackage Description
1NDC:69365-001-021 BLISTER PACK in 1 KIT
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(69365-001), pack(69365-001), analysis(69365-001), label(69365-001)

 
JW Holdings

Further information

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

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