ALGIDOL FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit

Algidol Flu by

Drug Labeling and Warnings

Algidol Flu by is a Otc medication manufactured, distributed, or labeled by Gelpharma S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients (in each softgel capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Uses

• temporarily relieves
• minor aches and pains associated with the common cold, sore throat, or headache
• cough associated with the common cold
• nasal congestion due to the common cold
• temporarily reduces fever
• helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take: Liver warning:

Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:

If a skin reaction occurs, stop use and seek medical help right away.

• more than 8 capsules 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

• skin reddening
• blisters
• rash 

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 or 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 for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
• if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor before use if 

you have liver disease.

Ask a doctor or pharmacist before use

if you are taking the blood thinning drug warfarin.

When using this product

• do not exceed the recommended dosage
• do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. If pain or fever persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.
• if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
• 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 decongestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
• if nervousness, dizziness, or sleeplessness occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• take only as directed
• do not exceed 8 capsules per 24 hours

• Adults & children 12 years & over: 2 capsules with water every 4 hours
• Children 4 to under 12 years: Consult a doctor
• Children under 4 years: Do not use

Other information

• do not exceed 77°F (25°C)
• avoid excessive heat

Inactive ingredients

gelatin, purified water, glycerin, polyethylene glycol 1000, propylene glycol, polyethylene glycol 600, povidone K30, orange flavor, FD&C Yellow No. 6, BHT, BHA.

Drug Facts

Active ingredients (in each softgel capsule)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

• temporarily relieves
• minor aches and pains associated with the common cold, sore throat, or headache
• cough associated with the common cold
• nasal congestion due to the common cold
• runny nose and alleviates sneezing, itching of the nose or throat, and itchy, watery eyes due to hay fever
• temporarily reduces fever

Warnings

This product contains acetaminophen. Severe liver damage may occur if you take: Liver warning:

Acetaminophen may cause severe skin reactions. Symptoms may include: Allergy alert:

If a skin reaction occurs, stop use and seek medical help right away.

• more than 8 capsules 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

• skin reddening
• blisters
• rash

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 or 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 for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• for persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema, or where cough is accompanied by excessive phlegm (mucus) unless directed by a doctor.
• if you have heart disease, high blood pressure, thyroid disease, diabetes, a breathing problem such as emphysema or chronic bronchitis, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor before use if

you have liver disease.

Ask a doctor or pharmacist before use if

you are taking the blood thinning drug warfarin.

When using this product

• do not exceed the recommended dosage
• do not take this product for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor. because these could be signs of a serious condition.
• if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
• if symptoms do not improve within 7 days or are accompanied by fever, consult a doctor.
• may cause excitability especially in children
• may cause marked drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor. Use caution when driving a motor vehicle or operating machinery.

Stop use and ask a doctor if

• pain or nasal decongestion gets worse or lasts more than 7 days
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur
• cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
• if nervousness, dizziness, or sleeplessness occur

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• take only as directed
• do not exceed 8 capsules per 24 hours

• Adults & children 12 years & over: 2 capsules with water every 4 hours
• Children 4 to under 12 years: Consult a doctor
• Children under 4 years: Do not use

Other information

• do not exceed 77°F (25°C)
• avoid excessive heat

Inactive ingredients

gelatin, purified water, polyethylene glycol 1000, glycerin, polyethylene glycol 600, propylene glycol, povidone K30, citric acid, mint flavor, FD&C Blue No. 1, FD&C Yellow No. 6, BHT, BHA.

Package Labeling:

INGREDIENTS AND APPEARANCE

ALGIDOL FLU 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69377-003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69377-003-01	1 in 1 CARTON	09/01/2022
1		1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 CAPSULE	2
Part 2	0 CAPSULE	1

Part 1 of 2

ALGIDOL DAYTIME 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride capsule

Product Information
Item Code (Source)	NDC: 69377-004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
POVIDONE K30 (UNII: U725QWY32X)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	10mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69377-004-01	2 in 1 BLISTER PACK
1		8 in 1 CAPSULE; 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	09/01/2022

Part 2 of 2

ALGIDOL NIGHTTIME 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule

Product Information
Item Code (Source)	NDC: 69377-005
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	6.25 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
WATER (UNII: 059QF0KO0R)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE K30 (UNII: U725QWY32X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)

Product Characteristics
Color	green	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69377-005-01	1 in 1 BLISTER PACK
1		8 in 1 CAPSULE; 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	09/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	09/01/2022

Labeler - Gelpharma S.A. de C.V. (812773665)