Right Remedies 

Right Remedies 
SPL v1
SPL
SPL Set ID 9f050fb0-6100-4b14-b82f-1d5fcbf16540
Route
ORAL
Published
Effective Date 2025-09-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Sorbitol Sorbitan Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-23

Description

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


Medication Information

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine succinate 6.25 mg Phenylephrine HCl 5 mg

Uses

• temporarily relieves common cold/flu symptoms:

   • nasal congestion  • sinus congestion & pressure 

   • cough due to minor throat & bronchial irritation 

   • cough to help you sleep  • minor aches & pains 

   • headache  • fever  • sore throat

• runny nose & sneezing  • reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Section 42229-5

Compare to the active ingredients in Vicks® NyQuil™ Severe Cold & Flu LiquiCaps™*

MAX STRENGTH

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® NyQuil™ LiquiCaps™.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

PRODUCT OF INDIA

Section 50565-1

Keep out of reach of children.

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take  • more than 8 softgels in 24 hours, which is the maximum daily amount for this product  • with other drugs containing acetaminophen  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:  • skin reddening  • blisters  • rash

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

Sore throat warning: 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.

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.

Ask a doctor before use if you have • liver disease  • heart disease  • high blood pressure  • thyroid disease  • diabetes  • glaucoma  • cough that occurs with too much phlegm (mucus)  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are  • taking sedatives or tranquilizers  • taking the blood thinning drug warfarin

When using this product • do not use more than directed

• excitability may occur, especially in children  • marked drowsiness may occur  • avoid alcoholic drinks  • be careful when driving a motor vehicle or operating machinery  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if  • you get nervous, dizzy, or sleepless  • pain, nasal congestion, or cough 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 comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

Packaging

Directions

 • take only as directed  • do not exceed 8 softgels per 24 hrs

 adults & children 12 yrs & over  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

Other Information 

• store at controlled room temperature 20–25°C (68–77°F)  • protect from light, heat, and moisture

Inactive Ingredients

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses

• temporarily relieves common cold/flu symptoms:

   • nasal congestion  • sinus congestion & pressure 

   • cough due to minor throat & bronchial irritation 

   • cough to help you sleep  • minor aches & pains 

   • headache  • fever  • sore throat

• runny nose & sneezing  • reduces swelling of nasal passages

• temporarily restores freer breathing through the nose

• promotes nasal and/or sinus drainage

Section 42229-5 (42229-5)

Compare to the active ingredients in Vicks® NyQuil™ Severe Cold & Flu LiquiCaps™*

MAX STRENGTH

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademarks Vicks® NyQuil™ LiquiCaps™.

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

PRODUCT OF INDIA

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purposes

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take  • more than 8 softgels in 24 hours, which is the maximum daily amount for this product  • with other drugs containing acetaminophen  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:  • skin reddening  • blisters  • rash

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

Sore throat warning: 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.

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.

Ask a doctor before use if you have • liver disease  • heart disease  • high blood pressure  • thyroid disease  • diabetes  • glaucoma  • cough that occurs with too much phlegm (mucus)  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema  • trouble urinating due to enlarged prostate gland

Ask a doctor or pharmacist before use if you are  • taking sedatives or tranquilizers  • taking the blood thinning drug warfarin

When using this product • do not use more than directed

• excitability may occur, especially in children  • marked drowsiness may occur  • avoid alcoholic drinks  • be careful when driving a motor vehicle or operating machinery  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if  • you get nervous, dizzy, or sleepless  • pain, nasal congestion, or cough 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 comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.

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

Packaging

Directions

 • take only as directed  • do not exceed 8 softgels per 24 hrs

 adults & children 12 yrs & over  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

Other Information  (Other information )

• store at controlled room temperature 20–25°C (68–77°F)  • protect from light, heat, and moisture

Inactive Ingredients (Inactive ingredients)

D&C Yellow No.10, FD&C Blue No.1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-577-8033 Monday - Friday 8am - 4pm EST

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

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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