Lil' Drug Store ®

Lil' Drug Store ®
SPL v7
SPL
SPL Set ID 747b4767-ed1d-4344-adea-1c849bc98fae
Route
ORAL
Published
Effective Date 2020-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Guaifenesin (200 mg) Phenylephrine (5 mg)
Inactive Ingredients
Maltodextrin Microcrystalline Cellulose Povidone, Unspecified Sodium Starch Glycolate Type A Corn Starch, Corn Stearic Acid Croscarmellose Sodium Hypromellose, Unspecified Polyethylene Glycol, Unspecified

Identifiers & Packaging

Pill Appearance
Imprint: AZ;273 Shape: round Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-02-03 Until 2018-02-11
Description

Drug Facts

Medication Information

Description

Drug Facts

Uses
  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt 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

  • 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 is accompanied by a fever, rash or persistent headache
  • nervousness, dizziness, or sleeplessness occur.

These could be signs of a serious condition.

Section 50567-7

When using this product

  • do not exceed recommended dosage
Section 50568-5

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
Section 53414-9

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

Section 55105-1
Active ingredients (in each tablet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
adults and children 12 years and over
  • take 2 tablets with water every 6-8 hours as needed
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
children under 12 years of age
  • 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.
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.
Other Information
  • do not use if carton or inner pouch is open or torn
  • store at room temperature 59-86° F (15-30° C)
  • avoid excessive heat and humidity
  • see bottom panel or pouch for expiration date and lot number
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.

Inactive Ingredients

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments?

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Principal Display Panel 6 Tablet Pouch Carton

QUALITY



GUARANTEED

on

the

Go

PACKS



Cold

Cold



Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

Non-Drowsy Relief of

  • Cough, Impulse to Cough
  • Nasal Congestion
  • Sore Throat

SEVERE

CONGESTION

6

Tablets

3 POUCHES, 2 TABLETS PER POUCH

Lil'

DrugStore ®

Principal Display Panel 20 Tablet Carton 9828

EZ Paks ™



Stores & Travels Easily!

Compare to the active ingredients in



Tylenol ® Cold Head Congestion*

NON-DROWSY FORMULA

Cold Relief



Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

SEVERE CONGESTION

Contains 4 Active Medicines:



Acetaminophen... relieves Headache, Sore Throat

Dextromethorphan HBr...relieves Coughing

Guaifenesin...relieves Chest Congestion

Phenylephrine HCl...relieves Nasal Congestion

20 TABLETS



IN 10 POUCHES OF 2 TABLETS

Lil'



Drug Store ®

Structured Label Content

Uses
  • for the temporary relief of the following cold/flu symptoms:
    • minor aches and pains
    • headache
    • sore throat
    • nasal congestion
    • cough
    • impulse to cough
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily reduces fever
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt 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

  • 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 is accompanied by a fever, rash or persistent headache
  • nervousness, dizziness, or sleeplessness occur.

These could be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product

  • do not exceed recommended dosage
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
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 tablet) Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan HBr 15 mg Cough suppressant
Guaifenesin 200 mg Expectorant
Phenylephrine HCl 5 mg Nasal decongestant
Directions
adults and children 12 years and over
  • take 2 tablets with water every 6-8 hours as needed
  • do not take more than 8 tablets in 24 hours, or as directed by a doctor
children under 12 years of age
  • 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.
Liver Warning (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.
Other Information (Other information)
  • do not use if carton or inner pouch is open or torn
  • store at room temperature 59-86° F (15-30° C)
  • avoid excessive heat and humidity
  • see bottom panel or pouch for expiration date and lot number
Sore Throat Warning (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.

Inactive Ingredients (Inactive ingredients)

maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate, starch, stearic acid

Questions Or Comments? (Questions or comments?)

call toll-free 1-877-507-6516 (M-F 8AM-4:30PM CST)

Principal Display Panel 6 Tablet Pouch Carton (PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton)

QUALITY



GUARANTEED

on

the

Go

PACKS



Cold

Cold



Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl

Pain Reliever/Fever Reducer, Cough Suppressant, Expectorant, Nasal Decongestant

Non-Drowsy Relief of

  • Cough, Impulse to Cough
  • Nasal Congestion
  • Sore Throat

SEVERE

CONGESTION

6

Tablets

3 POUCHES, 2 TABLETS PER POUCH

Lil'

DrugStore ®

Principal Display Panel 20 Tablet Carton 9828 (PRINCIPAL DISPLAY PANEL - 20 Tablet Carton - 9828)

EZ Paks ™



Stores & Travels Easily!

Compare to the active ingredients in



Tylenol ® Cold Head Congestion*

NON-DROWSY FORMULA

Cold Relief



Pain Reliever/Fever Reducer, Expectorant, Nasal Decongestant, Cough Suppressant

SEVERE CONGESTION

Contains 4 Active Medicines:



Acetaminophen... relieves Headache, Sore Throat

Dextromethorphan HBr...relieves Coughing

Guaifenesin...relieves Chest Congestion

Phenylephrine HCl...relieves Nasal Congestion

20 TABLETS



IN 10 POUCHES OF 2 TABLETS

Lil'



Drug Store ®

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.064601 · Updated: 2026-03-14T22:59:43.649746