FDA.reportPublic FDA data

Allergy Sinus, Lil Drug Store

Manufacturer
Lil' Drug Store Products, Inc.
Effective date
2024-02-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:08:30

Label at a glance#

ProductAllergy Sinus, Lil Drug Store
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

Uses temporarily relieves these symptoms of hay fever or other upper respiratory allergies: headache sinus congestion and pressure nasal congestion runny nose and sneezing minor aches and pains temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus openings and passages

Dosage and administration

Directions do not take more than directed adults and children 12 years and over take 2 tablets every 4 to 6 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 ask a doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

​Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Acetamionophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine Hydrochloride 5 mg

Purpose

OTC - PURPOSE SECTION

Purpose

Pain reliever

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches and pains
  • temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes
  • helps clear nasal passages
  • helps decongest sinus openings and passages

Warnings

WARNINGS SECTION

​Warnings

Liver warning

SPL UNCLASSIFIED SECTION

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

  • more than 4,000 mg of acetaminophen in 24 hours, which is the maximum daily amount.
  • with other drugs containing acetaminophen.
  • 3 or more alcoholic drinks every day while using this product.

Allergy alert

SPL UNCLASSIFIED SECTION

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.

Do not use

OTC - DO NOT USE SECTION

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.

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • glaucoma
  • diabetes
  • thyroid disease
  • high blood pressure
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you are

  • taking sedatives or tranquilizers.
  • taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage
  • excitability may occur, especially in children
  • drowsiness may occur
  • alcohol, sedatives and tranquilizers may increase drowsiness
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • nervousness, dizziness or sleeplessness occur
  • pain or nasal congestion 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 These could be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children

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. 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

Directions

  • do not take more than directed
adults and children 12 years and over
  • take 2 tablets every 4 to 6 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
  • ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Other information

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

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

Allergy Sinus, Lil' Drug Store ® - PDP/Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[caduceus]

on

the

Go

PACKS

Allergy

Sinus [tablets image]

Allergy Sinus

Acetaminophen, Chlorpheniramine maleate, Phenylephrine hydrochloride

Pain Reliever, Antihistamine, Nasal Decongestant

Relief of

  • Sinus Congestion & Pressure
  • Nasal Congestion
  • Runny Nose & Sneezing

6

Tablets

​ 3POUHES, 2 TABLETS PER POUCH

[Lil' Drug Store logo]

PDP/PackagePDP/Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN1
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD1
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
377068df-225f-7318-a910-a1987cdfa361Product name320170608
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9927-3Allergy Sinus, Lil Drug Store3 in 1 CARTONTABLET31
66715-9927-3Allergy Sinus, Lil Drug Store2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9927ALLERGY SINUS, LIL DRUG STORE (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATE) TABLET [LIL' DRUG STORE PRODUCTS, INC.]1Current NDC, 2 package rows20240214_1145440e-b37a-6e5e-e063-6294a90ab4a0.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
66715-992766715-9927-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE (15 MPA.S AT 5%)68401960MKIACT
STEARIC ACID4ELV7Z65APIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT

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
Allergy Sinus, Lil Drug StoreACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, CHLORPHENIRAMINE MALEATELil' Drug Store Products, Inc.1145440e-b37a-6e5e-e063-6294a90ab4a02024-02-13WarningsExact identifier
ndc (package): 66715-9927-3
ndc (product): 66715-9927
ndc11 (package): 66715992703
spl id: 1145440e-b37b-6e5e-e063-6294a90ab4a0
spl set id: 1145440e-b37a-6e5e-e063-6294a90ab4a0

Reported adverse events (FAERS/openFDA)#

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