ANTIFLU DES COUGH AND FLU- acetaminophen phenylephrine hcl chlorpheniramine maleate capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)

Available from:

Productos Farmaceuticos, S.A. de C.V.

Administration route:

ORAL

Prescription type:

OTC DRUG

Therapeutic indications:

Pain reliever/fever reducer Nasal decongestant Antihistamine Temporarily relieves common cold and flu symptoms: ▪sore throat ▪headache ▪minor aches and pains ▪fever ▪stuffy/runny nose and sneezing ▪ With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains Acetaminophen, ask a Doctor. If you are now taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or if you have taken these products 2 weeks previously. If you do not know if your prescription drug contains an MAOI, ask a Doctor before taking this product ▪ Liver disease ▪ Heart disease ▪ High blood pressure ▪ Thyroid disease ▪ Diabetes ▪Glaucoma ▪ Breathing problem due to any given cause (asthma, chronic bronchitis or emphysema) ▪ Trouble urinating due to an enlarged prostate gland ▪Taking sedatives or tranquilizers ▪Taking the blood thinning drug warfarin ▪ Pain, or nasal congestion gets worse

Authorization status:

OTC monograph final

Summary of Product characteristics

ANTIFLU DES COUGH AND FLU- ACETAMINOPHEN PHENYLEPHRINE HCL
CHLORPHENIRAMINE MALEATE CAPSULE
PRODUCTOS FARMACEUTICOS, S.A. DE C.V.
_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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ANTIDESCLDFLUCAPS
_ACTIVE INGREDIENTS_
Acetaminophen 325 mg
Phenylephrine HCl 10 mg
Chlorpheniramine Maleate 4 mg
_PURPOSE_
Pain reliever/fever reducer
Nasal decongestant
Antihistamine
_USES_
Temporarily relieves common cold and flu symptoms: ▪sore throat
▪headache ▪minor
aches and pains ▪fever ▪stuffy/runny nose and sneezing
_WARNINGS_
LIVER WARNING This product contains acetaminophen. Severe liver damage
may occur if
you take ▪More than 4,000 mg in 24 hours, which is the maximum daily
amount ▪ With
other drugs containing acetaminophen ▪ 3 or more alcoholic drinks
every day while
using this product.
ALLERGY ALERT: Acetaminophen may cause severe skin or severe allergic
reactions.
Symptoms can include▪ skin reddening ▪ blisters ▪ rash ▪ hives
▪ facial swelling ▪
asthma (wheezing) ▪ shock. If a skin or any allergic reaction
occurs, stop use and seek
medical attention right away.
SORE THROAT WARNING: Severe or persistent sore throat lasting more
than 2 days or
sore throat accompanied by high fever, headache, nausea, and vomiting
may be
serious. Consult a Doctor promptly.
DO NOT USE
▪ With any other drug containing acetaminophen (prescription or
nonprescription). If
you are not sure whether a drug contains Acetaminophen, ask a Doctor.
If you are now
taking a prescription Monoamine Oxidase Inhibitor (MAOI) (certain
drugs for depression,
psychiatric, or emotional conditions, or Parkinson's disease), or if
you have taken these
products 2 weeks previously. If you do not know if your prescription
drug contains an
MAOI, ask a Doctor before taking this product
_ASK A DOCTOR BEFORE USE IF YOU HAVE_
▪ Liver disease ▪ Heart disease ▪ High blood