GNP - 1157 - 2019-1001

Drug Labeling and Warnings

Drug Details [pdf]

SINUS RELIEF CONGESTION AND PAIN NIGHTTIME- acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated 
AmeriSource Bergen

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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GNP - 1157 - 2019-1001

Drug Facts

Active ingredients (in each caplet)	Purpose
Acetaminophen 325 mg	Pain reliever
Chlorpheniramine maleate 2 mg	Antihistamine
Phenylephrine HCl 5 mg	Nasal decongestant

Uses

• temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
  • headache
  • sinus congestion and pressure
  • nasal congestion
  • runny nose and sneezing
  • minor aches and pains
• temporarily relieves these additional symptoms of hay fever:
  • itching of the nose or throat
  • itchy, watery eyes
• helps clear nasal passages
• helps decongest sinus openings and passages

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

• more than 12 caplets in 24 hours, which is the maximum daily amount
• 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
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

• taking sedatives or tranquilizers
• taking the blood thinning drug warfarin

When using this product

• do not exceed recommended dosage
• excitability may occur, especially in children
• drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness
• avoid alcoholic drinks
• be careful when driving a motor vehicle or operating machinery

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

Taking more than the recommended dose (overdose) may cause liver damage. 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
  • swallow whole - do not crush, chew, or dissolve
  • do not take more than 12 caplets in 24 hours
• children under 12 years:
  • do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

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

Inactive ingredients

acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, flavor, hypromellose, iron oxide ochre, lactose anhydrous, magnesium stearate, povidone, pregelatinized starch, propylene glycol, stearic acid, titanium dioxide

PRINCIPAL DISPLAY PANEL

Good Neighbor Pharmacy®

Compare to Tylenol® Sinus Congestion & Pain Nighttime active ingredients†

NDC: 46122-074-62

See New Warnings Information

Nighttime

Sinus Relief Congestion & Pain

pain reliever, nasal decongestant, antihistamine

acetaminophen, phenylephrine hcl, chlorpheniramine maleate*

Relieves:

Headache

Sinus Pressure

Nasal Congestion

Runny Nose

24 cool taste caplets

SINUS RELIEF CONGESTION AND PAIN NIGHTTIME 
acetaminophen, chlorpheniramine maleate, and phenylephrine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 46122-074
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 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)
HYPROMELLOSES (UNII: 3NXW29V3WO)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE (UNII: FZ989GH94E)
STARCH, CORN (UNII: O8232NY3SJ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (Off-White)	Score	no score
Shape	OVAL	Size	17mm
Flavor	MINT	Imprint Code	AAA;1117
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46122-074-62	2 in 1 CARTON	10/28/2011	04/30/2019
1		12 in 1 BLISTER PACK; 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	10/28/2011	04/30/2019

Labeler - AmeriSource Bergen (007914906)

Revised: 10/2019

Document Id: 93e0b005-0c4e-dc6f-e053-2995a90a9da1

34390-5

Set id: 690ceabd-c8ad-45ff-9030-21200138ea88

Version: 3

Effective Time: 20191001