QCH - 1154 - 2019-1007

Drug Details [pdf]

SINUS RELIEF- acetaminophen and phenylephrine hydrochloride tablet, coated
Chain Drug Marketing Association

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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QCH - 1154 - 2019-1007

Drug Facts

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

temporarily relieves
- sinus congestion and pressure
- headache
- minor aches and pains
- nasal congestion

Warnings

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 10 caplets (3,250 mg acetaminophen) in 24 hours. 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.
if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

When using this product do not exceed the recommended dosage

Stop use and ask a doctor if

nervousness, dizziness, or sleeplessness occur
pain or nasal congestion gets worse or lasts more than 7 days
redness or swelling is present
fever gets worse or lasts more than 3 days
new symptoms 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.

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not take more than directed (see overdose warning)

adults and children 12 years and over	take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours
children under 12 years	ask a doctor

Other information

store between 20°-25°C (68°-77°F) in a dry place
retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C yellow #6, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide, triacetin

PRINCIPAL DISPLAY PANEL

NDC: 63868-972-24

QUALITY CHOICE

†Compare to SINUTAB® Sinus active ingredients

Maximum Strength, Non-Drowsy

Sinus Relief

Pain Reliever, Nasal Decongestant

Acetaminophen, Phenylephrine HCl

For Relief of:

Headache

Nasal Congestion

Sinus Pressure / Pain

24 Caplets

SEE NEW WARNINGS INFORMATION & DIRECTIONS

24 count

SINUS RELIEF
acetaminophen and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-972
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg

Ingredient Name	Strength
Inactive Ingredients
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	orange	Score	no score
Shape	OVAL	Size	17mm
Flavor		Imprint Code	AAA;114
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 63868-972-24	2 in 1 CARTON	10/09/2007	03/31/2019
1		12 in 1 BLISTER PACK; 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	10/09/2007	03/31/2019

Labeler - Chain Drug Marketing Association (011920774)

Revised: 10/2019

Document Id: 9457e123-2029-ea96-e053-2995a90a19d6

Set id: bf9b00c4-0f89-46c2-9651-abe6a4ab3fd3

Version: 3

Effective Time: 20191007

Chain Drug Marketing Association

QCH - 1154 - 2019-1007

Drug Labeling and Warnings

Drug Details [pdf]

QCH - 1154 - 2019-1007

Uses

Warnings

Liver warning

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Overdose warning

Directions

Other information

Inactive ingredients

PRINCIPAL DISPLAY PANEL