Gencare Daytime Cold And Flu Softgel (acetaminophen 325mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)

Gencare Daytime Cold And Flu Softgel (acetaminophen 325mg, Dextromethorphan Hbr 10mg, Phenylephrine Hcl 5mg)
SPL v3
SPL
SPL Set ID a9875dc9-6a27-413c-a2c7-68a86483ffc1
Route
ORAL
Published
Effective Date 2024-11-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Povidone Gelatin Sorbitol Glycerin Fd&c Red No. 40 Fd&c Yellow No. 6 Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-12-08

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer Dextromethorphan HBr 10mg..................... Cough suppressant Phenylephrine HCl 5mg ............................. Nasal decongestant


Medication Information

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer

Dextromethorphan HBr 10mg..................... Cough suppressant

Phenylephrine HCl 5mg ............................. Nasal decongestant

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Phenylephrine HCl 5mg

Uses:

temporarily relieves common cold/flu symptoms:

■ nasal congestion

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever

Section 34088-5

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for

adults & for children even if you do not notice any signs or symptoms.

Section 42229-5

This product is not manufactured or distributed by PROCTER & GAMBLE, owner of the registered trademark Vicks® Dayquil™ Cold and Flu LiquiCaps™.

Section 50565-1

Keep out of reach of children.

Section 50566-9
Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
Section 50567-7

When using this product do not use more than directed.

Section 50568-5
Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ thyroid disease

■ diabetes

■ high blood pressure

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough as occurs with smoking, asthma, or emphysema

Section 53414-9

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

Warning

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

■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,consult a doctor promptly.

Directions

■ take only as directed

■ do not exceed 4 doses per 24 hrs. 

 Adults and children 12 yrs and over take 2 softgels with water every 4 hrs. 
 Children 4 to under 12 yrs   ask a doctor
 Children under 4 yrs  do not use

Drug Facts

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.
Other Information

■ store at room temperature

Inactive Ingredients

Polyethylene Glycol400, Propylene Glycol, Povidone, Gelatin, Sorbitol Sorbitan Anhydrous, Glycerin, Allura Red, FD & C Yellow 6/Sunset Yellow, Titanium Dioxide.

Questions Or Comments?

Call 1-732-698-5070 Mon-Fri, 9am-5pm EST or visit: www.gencare.health.

Ndc 72090 005 01 48 Softgels

Active Ingredients (in Each Softgel)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg


Structured Label Content

Uses:

temporarily relieves common cold/flu symptoms:

■ nasal congestion

■ cough due to minor throat & bronchial irritation

■ sore throat

■ headache

■ minor aches & pains

■ fever

Section 34088-5 (34088-5)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for

adults & for children even if you do not notice any signs or symptoms.

Section 42229-5 (42229-5)

This product is not manufactured or distributed by PROCTER & GAMBLE, owner of the registered trademark Vicks® Dayquil™ Cold and Flu LiquiCaps™.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)
Stop use and ask a doctor if
  • you get nervous, dizzy or sleepless
  • pain, nasal congestion or cough get worse or last more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product do not use more than directed.

Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ liver disease

■ heart disease

■ thyroid disease

■ diabetes

■ high blood pressure

■ trouble urinating due to enlarged prostate gland

■ cough that occurs with too much phlegm (mucus)

■ persistent or chronic cough as occurs with smoking, asthma, or emphysema

Section 53414-9 (53414-9)

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

Purpose

Acetaminophen 325mg.....................Pain reliever/fever reducer

Dextromethorphan HBr 10mg..................... Cough suppressant

Phenylephrine HCl 5mg ............................. Nasal decongestant

Warning

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

■ more than 4 doses in 24 hrs, which is the maximum daily amount for this product ■ with other drugs containing acetaminophen ■ 3 or more alcoholic drinks daily while using this product.

Sore throat warning: If sore throat is severe, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,consult a doctor promptly.

Directions

■ take only as directed

■ do not exceed 4 doses per 24 hrs. 

 Adults and children 12 yrs and over take 2 softgels with water every 4 hrs. 
 Children 4 to under 12 yrs   ask a doctor
 Children under 4 yrs  do not use

Drug Facts

Do Not Use: (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.
Other Information (Other information)

■ store at room temperature

Inactive Ingredients (Inactive ingredients)

Polyethylene Glycol400, Propylene Glycol, Povidone, Gelatin, Sorbitol Sorbitan Anhydrous, Glycerin, Allura Red, FD & C Yellow 6/Sunset Yellow, Titanium Dioxide.

Questions Or Comments? (Questions or Comments?)

Call 1-732-698-5070 Mon-Fri, 9am-5pm EST or visit: www.gencare.health.

Ndc 72090 005 01 48 Softgels (NDC 72090-005-01- 48 Softgels)

Active Ingredients (in Each Softgel) (Active ingredients (in each softgel))

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Phenylephrine HCl 5mg


Advanced Ingredient Data


Raw Label Data

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