Right Remedies

Right Remedies
SPL v3
SPL
SPL Set ID 4db3e45a-39ef-4e54-aa01-5a8c1adea074
Route
ORAL
Published
Effective Date 2023-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg) Doxylamine (15 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin, Unspecified Glycerin Polyethylene Glycol 400 Povidone, Unspecified Propylene Glycol Water Sorbitol Sorbitan D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-05

Description

Drug Facts

Purpose

Pain reliever/Fever reducer Cough suppressant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms: • nasal congestion • cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pains • fever

Section 42229-5

Compare to the active ingredients of Vicks® DayQuil™ Cold & Flu Relief LiquiCaps™*

Compare to the active ingredients of Vicks® NyQuil™ Cold & Flu Relief LiquiCaps™*

RIGHT REMEDIES

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

Product of UAE

Packaged and Quality Assured in the USA

REV.00- 072022

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.

Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Warnings

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

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, lasts for more than 2 days, occurs with or is 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   • 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

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

When using this product, do not use more than directed.

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.

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

Packaging

Directions

• take only as directed - see overdose warning

• do not exceed 4 doses per 24 hrs

 adults and children 12 yrs & over 2 softgels with water every 4 hrs 
 children 4 to under 12 ask a doctor 
 children under 4 yrs do not use 

Right Remedies

Drug Facts

Other Information

• store at room temperature between 20-25°C (68-77°F)

Inactive Ingredients

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Questions Or Comments

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

Active Ingredients (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


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 42229-5 (42229-5)

Compare to the active ingredients of Vicks® DayQuil™ Cold & Flu Relief LiquiCaps™*

Compare to the active ingredients of Vicks® NyQuil™ Cold & Flu Relief LiquiCaps™*

RIGHT REMEDIES

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

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

Distributed by: Strive Pharmaceuticals Inc.,

East Brunswick, NJ 08816

Product of UAE

Packaged and Quality Assured in the USA

REV.00- 072022

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.

Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Purpose

Pain reliever/Fever reducer

Cough suppressant

Nasal decongestant

Warnings

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

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, lasts for more than 2 days, occurs with or is 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   • 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

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

When using this product, do not use more than directed.

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.

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

Packaging

Directions

• take only as directed - see overdose warning

• do not exceed 4 doses per 24 hrs

 adults and children 12 yrs & over 2 softgels with water every 4 hrs 
 children 4 to under 12 ask a doctor 
 children under 4 yrs do not use 

Right Remedies (RIGHT REMEDIES)

Drug Facts

Other Information (Other information)

• store at room temperature between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

edible white ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution

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

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)