Sinus and Headache Daytime: Package Insert and Label Information

SINUS AND HEADACHE DAYTIME- acetaminophen and phenylephrine hydrochloride tablet, film coated
L.N.K. International, 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.

Active ingredients (in each caplet)

Acetaminophen 325 mg
Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer
Nasal decongestant

Uses

  • temporarily relieves these symptoms associated with hay fever or other respiratory allergies, and the common cold:
    • headache
    • minor aches and pains
    • nasal congestion
    • sinus congestion and pressure
  • helps decongest sinus openings and passages
  • promotes sinus drainage
  • helps clear nasal passages
  • temporarily reduces fever

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:

  • blisters
  • rash
  • skin reddening

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.
  • 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
  • difficulty in urination due to enlargement of the prostate gland
  • heart disease
  • diabetes
  • thyroid disease
  • high blood pressure

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
  • new symptoms occur
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present

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 accidental overdose, get medical help or contact a Poison Control Center right away. Prompt 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
  • 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

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C red #40 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide

Questions or comments?

1-800-426-9391

Principal Display Panel

Quality +Plus

NDC 50844-467-08

*Compare to active ingredients in Tylenol® SINUS + HEADACHE

DAYTIME

Sinus & Headache

Acetaminophen
Phenylephrine HCl

PAIN RELIEVER / FEVER REDUCER
NASAL DECONGESTANT

•Sinus Headache • Sinus Pressure
•Nasal Congestion • Pseudoephedrine Free

24 Caplets NON-DROWSY

ACTUAL SIZE

TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Johnson & Johnson Corporation, owner of the registered trademark Tylenol® SINUS + HEADACHE.

Distributed by
LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788
USA

50844 REV0721B46608

Quality Plus 44-466C
(click image for full-size original)

Quality Plus 44-466C

SINUS AND HEADACHE DAYTIME
acetaminophen, phenylephrine hcl tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50844-467
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 325 mg
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
CROSPOVIDONE
D&C YELLOW NO. 10
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C RED NO. 40
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYVINYL ALCOHOL, UNSPECIFIED
POLYETHYLENE GLYCOL, UNSPECIFIED
POVIDONE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCRALOSE
TALC
TITANIUM DIOXIDE
Product Characteristics
Color green Score no score
Shape OVAL Size 17mm
Flavor MINT Imprint Code 44;466
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50844-467-02 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50844-467-02)
2 NDC:50844-467-08 2 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 12 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50844-467-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/26/2005
Labeler — L.N.K. International, Inc. (038154464)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867894 manufacture (50844-467)
Establishment
Name Address ID/FEI Operations
LNK International, Inc. 832867837 pack (50844-467)

Revised: 10/2021 L.N.K. International, Inc.

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