Nighttime Cold And Flu

Nighttime Cold And Flu
SPL v4
SPL
SPL Set ID bd12f7bd-1e9b-4ad4-b584-e8d1fa81c70c
Route
ORAL
Published
Effective Date 2024-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
Butylated Hydroxyanisole Fd&c Blue No. 1 Gelatin Glycerin Methylparaben Polyethylene Glycol 400 Propylene Glycol Propylparaben Povidone Sorbitol Water

Identifiers & Packaging

Pill Appearance
Imprint: SD26 Shape: capsule Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-06

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

• pain 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

• 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 n 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, & tranquilizers may increase drowsiness

Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if you have

• liver disease •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

Section 50570-1

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.

Section 53414-9

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

uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache• minor aches & pains• fever• runny nose & sneezing

Warnings

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

• more than 8 Softgels 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, persists 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 8 softgels per 24 hrs

• adults & children 12 yrs & over 2 Softgels with water every 6 hrs

• children 4 to under 12 yrs ask a doctor

• children under 4 yrs do not use

Other Information

• store between 20-25°C (68-77°F).

Avoid high humidity and excessive heat.

Protect from light.

Inactive Ingredients

butylated hydroxyanisole, FD&C Blue No. 1, gelatin, glycerin, methyl paraben, polyethylene glycol-400, propylene glycol, propyl Paraben, povidone, purified water, sorbitol

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

ValuRx

Compare to the Active Ingredients in Vicks® NyQuil® Cold & Flu LiquiCaps



Nighttime Cold & Flu



Multi-Symptom Relief



Acetaminophen

Dextromethorphan HBr

Doxylamine succinate



• Headache, Fever, Sore Throat,

• Minor Aches & Pain

• Sneezing, Runny Nose

• Cough

Carton

Active Ingredient (in Each Softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• pain 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

• 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 n 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, & tranquilizers may increase drowsiness

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers

• taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if you have

• liver disease •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

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

uses (Uses)

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

• headache• minor aches & pains• fever• runny nose & sneezing

Warnings

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

• more than 8 Softgels 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, persists 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 8 softgels per 24 hrs

• adults & children 12 yrs & over 2 Softgels with water every 6 hrs

• children 4 to under 12 yrs ask a doctor

• children under 4 yrs do not use

Other Information (Other information)

• store between 20-25°C (68-77°F).

Avoid high humidity and excessive heat.

Protect from light.

Inactive Ingredients (Inactive ingredients)

butylated hydroxyanisole, FD&C Blue No. 1, gelatin, glycerin, methyl paraben, polyethylene glycol-400, propylene glycol, propyl Paraben, povidone, purified water, sorbitol

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ValuRx

Compare to the Active Ingredients in Vicks® NyQuil® Cold & Flu LiquiCaps



Nighttime Cold & Flu



Multi-Symptom Relief



Acetaminophen

Dextromethorphan HBr

Doxylamine succinate



• Headache, Fever, Sore Throat,

• Minor Aches & Pain

• Sneezing, Runny Nose

• Cough

Carton

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)