Nighttime Cold And Flu Multi-symptom Relief

Nighttime Cold And Flu Multi-symptom Relief
SPL v2
SPL
SPL Set ID 38d14e50-6d8a-4569-a2db-aa5b86ffb6cd
Route
ORAL
Published
Effective Date 2026-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (30 mg) Doxylamine (12.5 mg)
Inactive Ingredients
Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Water Saccharin Sodium Sodium Benzoate Sodium Chloride Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-24

Description

Drug Facts

Purpose

Pain reliever/fever reducer Cough suppressant Antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

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

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 51945-4

Section 53414-9

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

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
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs 
adults & children 12 yrs & over 30 mL every 6 hrs 
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other Information
  • each 30 mL contains:sodium 24 mg
  • store between 20-25°C (68-77°F) and do not refrigerate.
Inactive Ingredients

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments?

1-800-373-6981(toll-free)

Principal Display Panel

ValuRx

Nighttime Cold & Flu

Multi-Symptom Relief

Label

Active Ingredient (in Each Softgel)

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

• cough due to minor throat & bronchial irritation

• sore throat

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

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 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Purpose

Pain reliever/fever reducer

Cough suppressant

Antihistamine

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
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs 
adults & children 12 yrs & over 30 mL every 6 hrs 
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Other Information (Other information)
  • each 30 mL contains:sodium 24 mg
  • store between 20-25°C (68-77°F) and do not refrigerate.
Inactive Ingredients (Inactive ingredients)

alcohol, citric acid, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose, xanthan gum

Questions Or Comments? (Questions or comments?)

1-800-373-6981(toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ValuRx

Nighttime Cold & Flu

Multi-Symptom Relief

Label

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

Acetaminophen 650 mg

Dextromethorphan HBr 30 mg

Doxylamine succinate 12.5 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)