Label: LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF- acetaminophen, guaifenesin, and phenylephrine hydrochloride tablet
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NDC Code(s):
66715-9744-1,
66715-9744-3,
66715-9744-8,
66715-9844-1, view more66715-9844-3, 66715-9844-8
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated December 21, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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, and hay fever and other upper respiratory allergies
- For the temporary relief of:
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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
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.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
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PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9744
Compare to the active ingredients in
Tylenol ® Sinus Congestion & Pain Severe*Multi-Symptom
Sinus Relief
NON-DROWSYPain Reliever, Nasal Decongestant, Expectorant
SEVERE CONGESTION
Contains 3 Active Medicines:
Acetaminophen...relieves Headache
Guaifenesin...relieves Chest Congestion
Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure6 TABLETS
Lil'
DrugStore ® -
PRINCIPAL DISPLAY PANEL - 6 Tablet Pouch Carton - 9844
Compare to the active ingredients in
Tylenol ® Sinus Congestion & Pain Severe*Multi-Symptom
Sinus Relief
NON-DROWSYPain Reliever, Nasal Decongestant, Expectorant
SEVERE CONGESTION
Contains 3 Active Medicines:
Acetaminophen...relieves Headache
Guaifenesin...relieves Chest Congestion
Phenylephrine HCl...relieves Nasal Congestion & Sinus Pressure6 TABLETS
Lil'
DrugStore ® -
INGREDIENTS AND APPEARANCE
LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9744 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Color pink Score no score Shape ROUND Size 12mm Flavor Imprint Code FR14 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9744-3 3 in 1 CARTON 06/01/2011 05/19/2024 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9744-8 10 in 1 CARTON 06/01/2011 01/09/2018 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-9744-1 30 in 1 CARTON 06/01/2011 01/09/2018 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2011 05/19/2024 LIL DRUG STORE MULTI-SYMPTOM SINUS RELIEF
acetaminophen, guaifenesin, and phenylephrine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9844 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ;286 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9844-3 3 in 1 CARTON 06/01/2011 07/13/2021 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9844-8 10 in 1 CARTON 06/01/2011 01/09/2018 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:66715-9844-1 30 in 1 CARTON 06/01/2011 01/09/2018 3 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/01/2011 07/13/2021 Labeler - Lil' Drug Store Products, Inc. (093103646)