Multi-symptom Nighttime Cold & Flu

Multi-symptom Nighttime Cold & Flu
SPL v5
SPL
SPL Set ID 8f614314-5945-470b-8114-81744db7d1ef
Route
ORAL
Published
Effective Date 2021-04-28
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
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: 215;902 Shape: capsule Color: green Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-04-28

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
  • runny nose and sneezing
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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
  • 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
  • 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
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.
  • to make a child sleep
Section 53414-9

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

Section 55105-1
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
Directions
  • Take only as recommended—see Overdose warning.
  • do not exceed 4 doses per 24 hours
    adults and children 12 years of age and over swallow 2 softgels with water every 6 hours
    children 4 to under 12 years of age ask a doctor
    children under 4 years of age do not use

If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

Overdose Warning

Overdose warning: Taking more than the recommended dose can cause serious health problems. 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.

Other Information
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain phenylpropanolamine
Inactive Ingredients

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments?

1-888-333-9792

Principal Display Panel

Nighttime



Multi-symptom



Cold & Flu

Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Relief of:

• Headache & Fever • Sore Throat • Minor Aches & Pains

• Cough • Sneezing & Runny Nose

10 Softgels


Structured Label Content

Uses

temporarily relieves common cold/flu symptoms:

  • cough due to minor throat and bronchial irritation
  • sore throat
  • headache
  • minor aches/pains
  • fever
  • runny nose and sneezing
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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
  • 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
  • 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
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.
  • to make a child sleep
Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients (in each softgel) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan Hydrobromide 15 mg Cough suppressant
Doxylamine Succinate 6.25 mg Antihistamine
Directions
  • Take only as recommended—see Overdose warning.
  • do not exceed 4 doses per 24 hours
    adults and children 12 years of age and over swallow 2 softgels with water every 6 hours
    children 4 to under 12 years of age ask a doctor
    children under 4 years of age do not use

If taking Nighttime and Daytime softgels carefully read each label to insure correct dosing

Overdose Warning (Overdose warning)

Overdose warning: Taking more than the recommended dose can cause serious health problems. 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.

Other Information (Other information)
  • store at room temperature 15°-30°C (59°-86°F) and avoid excessive heat
  • this product does not contain phenylpropanolamine
Inactive Ingredients (Inactive ingredients)

D&C Yellow No. 10, FD&C Blue No. 1, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan, titanium dioxide

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Nighttime



Multi-symptom



Cold & Flu

Acetaminophen - Pain Reliever / Fever Reducer

Dextromethorphan HBr - Cough Suppressant

Doxylamine Succinate - Antihistamine

Relief of:

• Headache & Fever • Sore Throat • Minor Aches & Pains

• Cough • Sneezing & Runny Nose

10 Softgels


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)