LIL DRUG STORE MULTI-SYMPTOM SINUS SEVERE CONGESTION- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

Lil Drug Store Multi-Symptom Sinus by

Drug Labeling and Warnings

Lil Drug Store Multi-Symptom Sinus by is a Otc medication manufactured, distributed, or labeled by Lil Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredients (in each tablet) Purpose

Acetaminophen 325 mg Pain reliever

Guaifenesin 200 mg Expectorant

Phenylephrine HCl 5 mg Nasal decongestant
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
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.
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.

Active ingredients (in each tablet)	Purpose
Acetaminophen 325 mg	Pain reliever
Guaifenesin 200 mg	Expectorant
Phenylephrine HCl 5 mg	Nasal decongestant

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 of age	consult a doctor

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

FD&C red #40, maltodextrin, microcrystalline cellulose, povidone, silicon dioxide1, sodium starch glycolate, starch, stearic acid

1 may contain

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 16 Tablet Pouch Carton

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

INGREDIENTS AND APPEARANCE

LIL DRUG STORE MULTI-SYMPTOM SINUS SEVERE CONGESTION
acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-6844
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)	Acetaminophen	325 mg
Guaifenesin (UNII: 495W7451VQ) (Guaifenesin - UNII:495W7451VQ)	Guaifenesin	200 mg
Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)	Phenylephrine Hydrochloride	5 mg

Ingredient Name	Strength
Inactive Ingredients
FD&C Red No. 40 (UNII: WZB9127XOA)
Maltodextrin (UNII: 7CVR7L4A2D)
Microcrystalline Cellulose (UNII: OP1R32D61U)
Povidone, Unspecified (UNII: FZ989GH94E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Starch Glycolate Type A Corn (UNII: AG9B65PV6B)
Starch, Corn (UNII: O8232NY3SJ)
Stearic Acid (UNII: 4ELV7Z65AP)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	12mm
Flavor		Imprint Code	FR14
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 66715-6844-8	8 in 1 CARTON	03/15/2018
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	12/15/2014

Labeler - Lil Drug Store Products, Inc (093103646)