695t 0363 0729 Walgreens - Daytime Nighttime Cold & Flu

695t 0363 0729 Walgreens - Daytime Nighttime Cold & Flu
SPL v5
SPL
SPL Set ID c945c35e-de0d-0fd6-e053-2995a90a1fbf
Route
ORAL
Published
Effective Date 2021-08-12
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 Polyethylene Glycol, Unspecified Povidone Sorbitan Titanium Dioxide Fd&c Yellow No. 6 Shellac Water Gelatin Glycerin Propylene Glycol Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Imprint: 71 Shape: oval Color: orange Color: green Size: 21 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-10-15

Description

Daytime Cold & Flu Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Nighttime Cold & Flu Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg


Medication Information

Warnings and Precautions

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
  • wilh other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Indications and Usage

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion (Daytime only)
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing (Nighttime only)
Dosage and Administration

Directions

  • take only as directed
  • do not exceed 4 doses per 24 hrs

adults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only)

2 softgels with water every 4 hrs (Daytime only)

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

Description

Daytime Cold & Flu Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg Nighttime Cold & Flu Active ingredients (in each softgel) Acetaminophen 325 mg Dextromethorphan HBr 15 mg Doxylamine succinate 6.25 mg

Section 50565-1

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). 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

  • you get nervous, dizzy or sleepless (Daytime only)
  • pain, nasal congestion or cough get worse or last more than 7days (Daytime only)
  • 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.
  • pain, or cough gets worse or lasts more than 7days (Nighttime only)
  • These could be signs of a serious condition.
Section 50567-7

When using this product

  • do not use more than directed (Daytime only)
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic drinks (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, & tranquilizers may increase drowsiness (Nighttime only)
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease (Daytime only)
  • high blood pressure (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • 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 (Daytime only)
  • glaucoma (Nighttime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis or emphysema (Nighttime only)

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 51727-6

Inactive ingredients (Daytime only)

FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Inactive ingredients (Nighttime only)

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Section 51945-4

Section 53413-1

Questions? Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Daytime Cold & Flu

Purpose


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Nighttime Cold & Flu

Purpose


Pain reliever/fever reducer

Cough suppressant

Antihistamine

Section 55106-9

Daytime Cold & Flu

Active ingredients (in each softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Nighttime Cold & Flu

Active ingredients (in each softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Other Information

Other information

  • store at room temperature

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves common cold/flu symptoms:

  • nasal congestion (Daytime only)
  • cough due to minor throat & bronchial irritation
  • sore throat
  • headache
  • minor aches and pains
  • fever
  • runny nose and sneezing (Nighttime only)
Dosage and Administration (34068-7)

Directions

  • take only as directed
  • do not exceed 4 doses per 24 hrs

adults & children 12yrs & over: 2 softgels with water every 6 hrs(Nighttime only)

2 softgels with water every 4 hrs (Daytime only)

children 4 to under 12 yrs: ask a doctor

children under 4 yrs: do not use

Warnings and Precautions (34071-1)

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
  • wilh other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

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.

Section 50565-1 (50565-1)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center righl away (1-800-222-1222). 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

  • you get nervous, dizzy or sleepless (Daytime only)
  • pain, nasal congestion or cough get worse or last more than 7days (Daytime only)
  • 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.
  • pain, or cough gets worse or lasts more than 7days (Nighttime only)
  • These could be signs of a serious condition.
Section 50567-7 (50567-7)

When using this product

  • do not use more than directed (Daytime only)
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • avoid alcoholic drinks (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
  • alcohol, sedatives, & tranquilizers may increase drowsiness (Nighttime only)
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease (Daytime only)
  • high blood pressure (Daytime only)
  • thyroid disease (Daytime only)
  • diabetes (Daytime only)
  • 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 (Daytime only)
  • glaucoma (Nighttime only)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma,chronic bronchitis or emphysema (Nighttime only)

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 51727-6 (51727-6)

Inactive ingredients (Daytime only)

FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Inactive ingredients (Nighttime only)

FD&C blue #1, FD&C yellow #10, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? Call 1-877-290-4008

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Daytime Cold & Flu

Purpose


Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Nighttime Cold & Flu

Purpose


Pain reliever/fever reducer

Cough suppressant

Antihistamine

Section 55106-9 (55106-9)

Daytime Cold & Flu

Active ingredients (in each softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Nighttime Cold & Flu

Active ingredients (in each softgel)


Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine succinate 6.25 mg

Other Information (OTHER INFORMATION)

Other information

  • store at room temperature

Advanced Ingredient Data


Raw Label Data

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