FACOL COLD AND FLU DAY AND NIGHT- acetaminphen, guaifenesin, phenylephrine hcl, dextromethorphan hbr, diphenhydramine hcl, lac c

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M), DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)

Available from:

JW HOLDINGS

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE

Composition:

DIPHENHYDRAMINE HYDROCHLORIDE 18.75 mg

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph not final

Summary of Product characteristics

FACOL COLD AND FLU DAY AND NIGHT- ACETAMINPHEN, GUAIFENESIN,
PHENYLEPHRINE HCL, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, LAC
COLOR,
GARDENIA BLUE CAPSULE, LIQUID FILLED
JW HOLDINGS
_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._
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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)