LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet 
Lil' Drug Store Products, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lil' Drug Store ® Multi-Symptom Sinus Relief

Drug Facts

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

Uses

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.

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 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

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

When using this product

  • do not exceed recommended dosage.

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.

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. (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

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
  • consult a doctor

Other information

Inactive ingredients

corn starch 1, croscarmellose sodium 1, FD&C red #40 1, hypromellose 1, maltodextrin 1, microcrystalline cellulose, polyethylene glycol 1, povidone 1, sodium starch glycolate 1, starch 1, stearic acid


1
may contain

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9744

Compare to the active ingredients in
Tylenol ® Sinus Congestion & Pain Severe*

Multi-Symptom
Sinus Relief

NON-DROWSY

Pain Reliever, Nasal Decongestant, Expectorant

SEVERE CONGESTION

Contains 3 Active Medicines:
Acetaminophen...relieves Headache
Guaifenesin...relieves Chest Congestion
Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure

6 TABLETS

Lil'
DrugStore ®

Principal Display Panel - 6 Tablet Pouch Carton - 9744

PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9844

Compare to the active ingredients in
Tylenol ® Sinus Congestion & Pain Severe*

Multi-Symptom
Sinus Relief

NON-DROWSY

Pain Reliever, Nasal Decongestant, Expectorant

SEVERE CONGESTION

Contains 3 Active Medicines:
Acetaminophen...relieves Headache
Guaifenesin...relieves Chest Congestion
Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure

6 TABLETS

Lil'
DrugStore ®

Principal Display Panel - 6 Tablet Pouch Carton - 9844
LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF 
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9744
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize12mm
FlavorImprint Code FR14
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9744-33 in 1 CARTON06/01/201105/19/2024
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:66715-9744-810 in 1 CARTON06/01/201101/09/2018
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:66715-9744-130 in 1 CARTON06/01/201101/09/2018
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/201105/19/2024
LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF 
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66715-9844
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize12mm
FlavorImprint Code AZ;286
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66715-9844-33 in 1 CARTON06/01/201107/13/2021
12 in 1 POUCH; Type 0: Not a Combination Product
2NDC:66715-9844-810 in 1 CARTON06/01/201101/09/2018
22 in 1 POUCH; Type 0: Not a Combination Product
3NDC:66715-9844-130 in 1 CARTON06/01/201101/09/2018
32 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/01/201107/13/2021
Labeler - Lil' Drug Store Products, Inc. (093103646)

Revised: 12/2021
Document Id: d3ae0396-2a76-39e4-e053-2a95a90ae5c4
Set id: 2819611c-4d87-4295-9985-8611278840e7
Version: 7
Effective Time: 20211221
 
Lil' Drug Store Products, Inc.