walgreens sinus relief daytime nighttime cold & flu

walgreens sinus relief daytime nighttime cold & flu
SPL v4
SPL
SPL Set ID da046b01-707c-326a-e053-2995a90a0927
Route
oral
Published
Effective Date 2022-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) dextromethorphan (10 mg) doxylamine (6.25 mg) phenylephrine (5 mg) guaifenesin (200 mg)
Inactive Ingredients
fd&c blue no. 1 gelatin glycerin polyethylene glycol, unspecified povidone propylene glycol water sorbitan sorbitol shellac titanium dioxide fd&c yellow no. 6

Identifiers & Packaging

Pill Appearance
Imprint: 78 Shape: capsule Color: green Color: orange Size: 21 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-06-01

Description

Nighttime Sinus Relief


Medication Information

Warnings and Precautions

Warnings

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

• more than 12 softgels in 24 hours, which is the maximum daily amount

• 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.



Active Ingredient

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 5 mg

Indications and Usage

Uses

• temporarily relieves common cold/flu symptoms:

nasal congestion

headache

cough

minor aches and pains

sinus congestion and pressure

runny nose and sneezing

• temporarily promotes nasal and/or sinus drainage

Dosage and Administration

Directions

  • do not take more than directed (see Overdose Warning)
  • do not take more than 12 softgels per in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours.
  • children under 12 years of age: do not use
Description

Nighttime Sinus Relief

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat
Section 50565-1

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• pain, nasal congestion, 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 fever, 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
Section 50568-5

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

• taking sedatives or tranquilizers



Section 50569-3

Ask a doctor before use if you have

• liver disease

• heart disease

• diabetes

• high blood pressure

• thyroid disease

• trouble urinating due to enlarged prostate gland

• glaucoma

• breathing problems such as emphysema or chronic bronchitis

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough that occurs with too much phlegm (mucus)



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

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

Section 51945-4

Section 53413-1

Questions or Comments?

Call 1-877-290-4008

Section 53414-9

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

Section 55105-1

Purposes

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Drug Facts Nighttime Sinus Relief

Nighttime Sinus Relief


Structured Label Content

Warnings and Precautions (34071-1)

Warnings

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

• more than 12 softgels in 24 hours, which is the maximum daily amount

• 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.



Active Ingredient (55106-9)

Active ingredients (in each softgel)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Doxylamine succinate 6.25 mg

Phenylephrine HCI 5 mg

Indications and Usage (34067-9)

Uses

• temporarily relieves common cold/flu symptoms:

nasal congestion

headache

cough

minor aches and pains

sinus congestion and pressure

runny nose and sneezing

• temporarily promotes nasal and/or sinus drainage

Dosage and Administration (34068-7)

Directions

  • do not take more than directed (see Overdose Warning)
  • do not take more than 12 softgels per in any 24-hour period
  • adults and children 12 years of age and older: take 2 softgels every 4 hours.
  • children under 12 years of age: do not use
Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
  • avoid excessive heat
Section 50565-1 (50565-1)

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occur

• pain, nasal congestion, 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 fever, 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
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
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



Section 50569-3 (50569-3)

Ask a doctor before use if you have

• liver disease

• heart disease

• diabetes

• high blood pressure

• thyroid disease

• trouble urinating due to enlarged prostate gland

• glaucoma

• breathing problems such as emphysema or chronic bronchitis

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

• cough that occurs with too much phlegm (mucus)



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

FD&C blue #1, 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 or Comments?

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)

Purposes

Pain reliever

Cough suppressant

Antihistamine

Nasal decongestant

Drug Facts Nighttime Sinus Relief (DRUG FACTS - Nighttime Sinus Relief)

Nighttime Sinus Relief


Advanced Ingredient Data


Raw Label Data

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