FDA.reportPublic FDA data

Lil Drug Store Multi-Symptom Sinus

Manufacturer
Lil Drug Store Products, Inc
Effective date
2022-10-05
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:52:21

Label at a glance#

ProductLil Drug Store Multi-Symptom Sinus Severe Congestion
Active ingredientACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

For the temporary relief of: sinus congestion and pressure nasal congestion headache minor aches and pains helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies

Dosage and administration

adults and children 12 years and over take 1-2 tablets every 4 hours as needed do not take more than 12 tablets in 24 hours, or as directed by a doctor children under 12 years of age consult a doctor

Storage and handling

store at room temperature 59-86°F (15-30°C) avoid excessive heat and humidity

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet)Purpose
Acetaminophen 325 mgPain reliever
Guaifenesin 200 mgExpectorant
Phenylephrine HCl 5 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of:
    • sinus congestion and pressure
    • nasal congestion
    • headache
    • minor aches and pains
  • helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive
  • temporarily relieves nasal congestion due to the common cold, hay fever and other upper respiratory allergies

Warnings

WARNINGS SECTION

Liver warning

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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.

Do not use

OTC - DO NOT USE SECTION

  • 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.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over
  • take 1-2 tablets every 4 hours as needed
  • do not take more than 12 tablets in 24 hours, or as directed by a doctor
children under 12 years of age
  • consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 59-86°F (15-30°C)
  • avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide 1, sodium starch glycolate, starch, stearic acid

1 may contain

Questions or comments?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 16 Tablet Pouch Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QUALITY
GUARANTEED

Compare to the Active Ingredients
in Tylenol® Sinus Severe †

Sinus
Relief

on
the
Go
PACKS

Multi-Symptom
Sinus

Acetaminophen, Guaifenesin, Phenylephrine HCl
Pain Reliever, Expectorant, Nasal Decongestant

Non-Drowsy Relief of

  • Chest Congestion
  • Nasal Congestion
  • Sinus Pressure

SEVERE
CONGESTION

16
Tablets
8 POUCHES, 2 TABLETS PER POUCH

Lil'
DrugStore ®

PRINCIPAL DISPLAY PANEL - 16 Tablet Pouch Carton
PRINCIPAL DISPLAY PANEL - 16 Tablet Pouch Carton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-6844LIL DRUG STORE MULTI-SYMPTOM SINUS SEVERE CONGESTION (ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET [LIL DRUG STORE PRODUCTS, INC]5Legacy NDC20221007_cd2c5383-a4a9-4331-847b-9e47fdc41b97.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66715-684466715-6844-8

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB
GUAIFENESIN495W7451VQACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ea50a317-6726-8bdc-e053-2a95a90ada14cd2c5383-a4a9-4331-847b-9e47fdc41b972022-10-05WarningsExact identifier
spl id: ea50a317-6726-8bdc-e053-2a95a90ada14
spl set id: cd2c5383-a4a9-4331-847b-9e47fdc41b97

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.