Dollar General 44-503a473c

Dollar General 44-503a473c
SPL v13
SPL
SPL Set ID acdcc6ce-c190-4de6-b126-62fe9043112e
Route
ORAL
Published
Effective Date 2025-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (10 mg) Guaifenesin (200 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Starch, Corn Crospovidone, Unspecified D&c Yellow No. 10 Aluminum Lake Magnesium Stearate Maltodextrin Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Povidone, Unspecified Silicon Dioxide Sodium Starch Glycolate Type A Potato Stearic Acid Sucralose Talc Titanium Dioxide Fd&c Blue No. 1 Aluminum Lake Fd&c Blue No. 2 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 44;473 Shape: oval Color: yellow Color: blue Size: 19 mm Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2005-08-04

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Description

Acetaminophen 325 mg Dextromethorphan HBr 10 mg Guaifenesin 200 mg Phenylephrine HCl 5 mg

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • headache
    • sore throat
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure 
    • sneezing and runny nose  (Nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive  (Daytime only)
  • helps clear nasal passages 
  • relieves cough to help you sleep 
  • temporarily reduces fever
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.

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
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole – do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor
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
Other Information
  • each caplet contains: sodium 3 mg
  • 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
Questions Or Comments?

1-888-309-9030

Principal Display Panel

DG™ | health

Compare to

active ingredients of

Tylenol® COLD + FLU

SEVERE Day & Night*

Severe • Day Time

Cold & Flu

Acetaminophen,

Dextromethorphan HBr,

Guaifenesin, Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant,

Expectorant, Nasal Decongestant

16 Caplets

Actual Caplet Size

Severe • Night Time

Cold & Flu

Acetaminophen,

Chlorpheniramine Maleate,

Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever/Fever Reducer, Antihistamine,

Cough Suppressant, Nasal Decongestant

8 Caplets

Actual Caplet Size

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 Kenvue Inc., owner

of the registered trademark Tylenol® COLD + FLU SEVERE Day & Night.

50844                 REV0922B50347308

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!


(888)309-9030

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do Not Take Daytime and

Nighttime Products at the

Same Time.

  

Dollar General 44-503A473C

When Using This Product
  • do not exceed recommended dosage
  • excitability may occur, especially in children  (Nighttime only)
  • marked drowsiness may occur  (Nighttime only)
  • avoid alcoholic beverages  (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery  (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness  (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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days 
  • redness or swelling is present
  • 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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

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

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Inactive Ingredients (nighttime Only)

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

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) (daytime Cold & Flu Severe)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime Cold & Flu Severe)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Structured Label Content

Uses
  • temporarily relieves these common cold and flu symptoms:
    • cough
    • headache
    • sore throat
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure 
    • sneezing and runny nose  (Nighttime only)
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive  (Daytime only)
  • helps clear nasal passages 
  • relieves cough to help you sleep 
  • temporarily reduces fever
Purpose

Pain reliever/fever reducer

Cough suppressant

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.

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
  • do not take more than directed
  • adults and children 12 years and over
    • take 2 caplets every 4 hours
    • swallow whole – do not crush, chew, or dissolve
    • do not take more than 10 caplets in 24 hours
  • children under 12 years: ask a doctor
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
Other Information (Other information)
  • each caplet contains: sodium 3 mg
  • 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
Questions Or Comments? (Questions or comments?)

1-888-309-9030

Principal Display Panel (Principal display panel)

DG™ | health

Compare to

active ingredients of

Tylenol® COLD + FLU

SEVERE Day & Night*

Severe • Day Time

Cold & Flu

Acetaminophen,

Dextromethorphan HBr,

Guaifenesin, Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant,

Expectorant, Nasal Decongestant

16 Caplets

Actual Caplet Size

Severe • Night Time

Cold & Flu

Acetaminophen,

Chlorpheniramine Maleate,

Dextromethorphan HBr, Phenylephrine HCl

Pain Reliever/Fever Reducer, Antihistamine,

Cough Suppressant, Nasal Decongestant

8 Caplets

Actual Caplet Size

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 Kenvue Inc., owner

of the registered trademark Tylenol® COLD + FLU SEVERE Day & Night.

50844                 REV0922B50347308

DISTRIBUTED BY

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100%

Satisfaction

Guaranteed!


(888)309-9030

PARENTS:

Learn about teen medicine abuse

www.StopMedicineAbuse.org

Do Not Take Daytime and

Nighttime Products at the

Same Time.

  

Dollar General 44-503A473C

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)
  • avoid alcoholic beverages  (Nighttime only)
  • use caution when driving a motor vehicle or operating machinery  (Nighttime only)
  • alcohol, sedatives, and tranquilizers may increase drowsiness  (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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days 
  • redness or swelling is present
  • 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 overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Do not take DAYTIME and NIGHTTIME products at the same time.

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

corn starch, crospovidone, D&C yellow #10 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

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

corn starch, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

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) (daytime Cold & Flu Severe) (Active ingredients (in each caplet) (Daytime Cold & Flu Severe))

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Active Ingredients (in Each Caplet) (nighttime Cold & Flu Severe) (Active ingredients (in each caplet) (Nighttime Cold & Flu Severe))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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