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

Antiflu Des by

Drug Labeling and Warnings

Antiflu Des by is a Otc medication manufactured, distributed, or labeled by Productos Farmaceuticos, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 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

Ask a Doctor before use if you are

▪Taking sedatives or tranquilizers ▪Taking the blood thinning drug warfarin

When using this product

▪ Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult a Doctor. ▪ Do not mix with alcohol, sedatives and tranquilizers as they may increase drowsiness ▪ Driving a motor vehicle or operating machinery could be affected ▪ Excitability may occur especially in children(12-18 y) ▪ if symptoms do not improve within 7 days or are accompanied by fever, consult a Doctor

Stop use and ask a Doctor if

▪ Pain, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults) ▪ Fever gets worse or last more than 3 days ▪ Redness or swelling is present ▪ New symptoms occur

Keep out of reach of children

If pregnant or breast-feeding, ask a health professional before use .

As with all medical products keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

▪ Do not take more than recommended dose Adults and children 12 years of age and over: take 1 capsule with water every 4 hours. ▪ Do not exceed 6 capsules in 24 hours Children under 12 years of age: do not use

Other information

Do not store above 77ºF(25ºC) and in a dry place

Inactive Ingredients

Colloidal Silcon Dioxide, D&C Red No. 28, D&C Red No. 33, D&C Yellow No. 10, FD&C Blue No. 1, Gelatin, Lactose Monohdyrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Shellac, Synthetic Iron Oxide, Titanium Dioxide

Questions and Comments?

You may report any side effects to 1-305-677-0850 Monday through Sunday 24 hrs

Package Label

INGREDIENTS AND APPEARANCE

ANTIFLU DES  COUGH AND FLU
acetaminophen phenylephrine hcl chlorpheniramine maleate capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82688-001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
POVIDONE (UNII: FZ989GH94E)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SHELLAC (UNII: 46N107B71O)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	gray (gray and orange)	Score	no score
Shape	CAPSULE (immediate release hard gelatin)	Size	24mm
Flavor		Imprint Code	ANTIDESFLU
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82688-001-12	1 in 1 CARTON	04/15/2022
1		12 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 Drug	M012	04/15/2022

Labeler - Productos Farmaceuticos, S.A. de C.V. (815664461)

Establishment
Name	Address	ID/FEI	Business Operations
Productos Farmaceuticos, S.A. de C.V.		815664461	manufacture(82688-001)