Target 44-615694-sm

Target 44-615694-sm
SPL v9
SPL
SPL Set ID a2b9a91f-fb92-4b4a-8ec4-7002bba06be6
Route
ORAL
Published
Effective Date 2024-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Diphenhydramine (12.5 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified Fd&c Red No. 40 Fd&c Yellow No. 6 Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Talc Titanium Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake Ferric Oxide Yellow Methacrylic Acid And Ethyl Acrylate Copolymer Sodium Bicarbonate

Identifiers & Packaging

Pill Appearance
Imprint: 44;694 Shape: oval Color: orange Color: blue Size: 19 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-07-01 Until 2026-03-27

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • cough (Nighttime only)
    • runny nose and sneezing (Nighttime only)
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.

Directions
  • do not use more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use
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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other product containing diphenhydramine, even one used on skin (Nighttime only)
Questions?

Call 1-800-910-6874

Other Information
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Principal Display Panel
  NDC 11673-694-09

Compare to active ingredients in

Maximum  Strength Mucinex®

SINUS-MAX® Day*

maximum strength

daytime sinus

acetaminophen

guaifenesin, phenylephrine HCl

pain reliever, expectorant,

nasal decongestant

ACTUAL

SIZE

AGES

12+

YEARS

12

CAPLETS

up&up™

Compare to active ingredients in

Maximum Strength Mucinex®

SINUS-MAX® Night*

maximum strength

nighttime sinus

acetaminophen

diphenhydramine HCl,

phenylephrine HCl

pain reliever,

antihistamine/cough suppressant,

nasal decongestant

ACTUAL

SIZE

AGES

12+

YEARS

8

CAPLETS

up&up™

12 DAY AND 8 NIGHT

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the

registered trademark Maximum Strength Mucinex® SINUS-MAX® Day & Night.

50844      REV0517B61569409

Distributed by Target Corp., Minneapolis, MN 55403

TM & ©2021 Target Brands, Inc.

Questions? Call 1-800-910-6874

Target 44-615694
When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
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 rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Ask A Doctor Before Use If You Have
  • heart disease
  • liver disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)
Inactive Ingredients (daytime Only)

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only)

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Active Ingredients (in Each Caplet) (sinus Day)

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)
Active Ingredients (in Each Caplet) (sinus Night)

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses
  • temporarily relieves:
    • nasal congestion
    • headache
    • minor aches and pains
    • sinus congestion and pressure
    • cough (Nighttime only)
    • runny nose and sneezing (Nighttime only)
  • temporarily promotes nasal and/or sinus drainage
  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
Purpose

Pain reliever

Expectorant

Nasal decongestant

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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.

Directions
  • do not use more than directed
  • do not take more than 12 caplets in any 24-hour period
  • adults and children 12 years and over: take 2 caplets every 4 hours
  • children under 12 years: do not use
Do Not Use (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.
  • if you have ever had an allergic reaction to this product or any of its ingredients
  • with any other product containing diphenhydramine, even one used on skin (Nighttime only)
Questions?

Call 1-800-910-6874

Other Information (Other information)
  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number
Principal Display Panel
  NDC 11673-694-09

Compare to active ingredients in

Maximum  Strength Mucinex®

SINUS-MAX® Day*

maximum strength

daytime sinus

acetaminophen

guaifenesin, phenylephrine HCl

pain reliever, expectorant,

nasal decongestant

ACTUAL

SIZE

AGES

12+

YEARS

12

CAPLETS

up&up™

Compare to active ingredients in

Maximum Strength Mucinex®

SINUS-MAX® Night*

maximum strength

nighttime sinus

acetaminophen

diphenhydramine HCl,

phenylephrine HCl

pain reliever,

antihistamine/cough suppressant,

nasal decongestant

ACTUAL

SIZE

AGES

12+

YEARS

8

CAPLETS

up&up™

12 DAY AND 8 NIGHT

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER

UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Reckitt Benckiser LLC, owner of the

registered trademark Maximum Strength Mucinex® SINUS-MAX® Day & Night.

50844      REV0517B61569409

Distributed by Target Corp., Minneapolis, MN 55403

TM & ©2021 Target Brands, Inc.

Questions? Call 1-800-910-6874

Target 44-615694
When Using This Product (When using this product)
  • do not exceed recommended dosage
  • excitability may occur, especially in children (Nighttime only)
  • marked drowsiness may occur (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
  • avoid alcoholic beverages (Nighttime only)
  • be careful when driving a motor vehicle or operating machinery (Nighttime only)
Stop Use and Ask A Doctor If (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 rash or headache that lasts.

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • heart disease
  • liver disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
  • glaucoma (Nighttime only)
Inactive Ingredients (daytime Only) (Inactive ingredients (Daytime only))

corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide

Inactive Ingredients (nighttime Only) (Inactive ingredients (Nighttime only))

corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide

Active Ingredients (in Each Caplet) (sinus Day) (Active ingredients (in each caplet) (Sinus Day))

Acetaminophen 325 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)
Active Ingredients (in Each Caplet) (sinus Night) (Active ingredients (in each caplet) (Sinus Night))

Acetaminophen 325 mg

Diphenhydramine HCl 12.5 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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