ACETAMINOPHEN SINUS CONGESTION AND PAIN DAYTIME- acetaminophen and phenylephrine hydrochloride tablet, coated 
Kinray 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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Acetaminophen Sinus Congestion & Pain Daytime

Drug Facts

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

Uses

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 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
  • 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, 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

adults and children 12 years and over
  • take 2 caplets every 4 hours
  • swallow whole – do not crush, chew, or dissolve
  • do not take more than 10 caplets in 24 hours
children under 12 years
  • ask a doctor

Other information

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide,croscarmellose sodium, D&C yellow #10, FD&C blue #1, flavor, hypromellose, lactose, magnesium stearate, povidone, pregelatinized starch, propylene glycol, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

Call 609-288-6060

Distributed by: Kinray Inc., 152-35 10th Ave., Whitestone, NY 11357

PRINCIPAL DISPLAY PANEL - 24 Caplet Blister Pack Carton

Preferred
plus
Pharmacy
®

NDC 61715-068-24

†Compare to the Active Ingredients in
Tylenol® Sinus Congestion & Pain Daytime

SATISFACTION
Preferred
plus
Pharmacy
®
GUARANTEED

ACETAMINOPHEN

Pain Reliever /
Fever Reducer

Nasal Decongestant

SINUS
CONGESTION
& PAIN For Adults

DAYTIME
NON-DROWSY

24
Cool Taste
Caplets

FOR RELIEF OF:

• SINUS HEADACHE - Acetaminophen
• NASAL CONGESTION
• SINUS PRESSURE

Phenylephrine HCl

SEE NEW WARNINGS INFORMATION & DIRECTIONS

Principal Display Panel - 24 Caplet Blister Pack Carton
ACETAMINOPHEN SINUS CONGESTION AND PAIN DAYTIME 
acetaminophen and phenylephrine hydrochloride tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-068
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
LACTOSE (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONES (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)  
Product Characteristics
Color GREEN Score no score
Shape OVAL Size 17mm
Flavor MINT Imprint Code AAA;1114
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:61715-068-24 2 in 1 CARTON
1 12 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 12/28/2012
Labeler - Kinray Inc. (012574513)

Revised: 6/2014
Document Id: bc7df9c1-3c93-4f84-90d3-51f5ccb491cd
Set id: b7cebd4a-33c5-4f7e-b6a8-1d5ba026c65d
Version: 1
Effective Time: 20140611
 
Kinray Inc.