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NDC 50269-0151-00 ALKA SELTZER PLUS 1S BLISTER PACK 325; 2; 7.8 mg/1; mg/1; mg/1 Details

ALKA SELTZER PLUS 1S BLISTER PACK 325; 2; 7.8 mg/1; mg/1; mg/1

ALKA SELTZER PLUS 1S BLISTER PACK is a ORAL TABLET, EFFERVESCENT in the HUMAN OTC DRUG category. It is labeled and distributed by JC World Bell Wholesale Co., Inc.. The primary component is ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE.

Product Information

NDC	50269-0151
Product ID	50269-151_dc66b2fe-1c20-ad07-e053-2995a90a49f9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ALKA SELTZER PLUS 1S BLISTER PACK
Proprietary Name Suffix	n/a
Non-Proprietary Name	ASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATE
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, EFFERVESCENT
Route	ORAL
Active Ingredient Strength	325; 2; 7.8
Active Ingredient Units	mg/1; mg/1; mg/1
Substance Name	ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE
Labeler Name	JC World Bell Wholesale Co., Inc.
Pharmaceutical Class	Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor An
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part341
Listing Certified Through	2023-12-31

Package

Package Images

NDC 50269-0151-00 (50269015100)

Pricing Information	N/A
NDC Package Code	50269-151-00
Billing NDC	50269015100
Package	6 BLISTER PACK in 1 BOX (50269-151-00) / 1 POUCH in 1 BLISTER PACK / 2 TABLET, EFFERVESCENT in 1 POUCH
Marketing Start Date	2019-10-30
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL abb4a104-266b-4ce9-ab5f-5ee1760957e4 Details

Drug Facts

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Chlorpheniramine maleate 2 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Uses

temporarily relieves these symptoms due to a cold:
minor aches and pains
headache
runny nose
nasal and sinus congestion
sneezing
sore throat
temporarily reduces fever

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptom could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

hives
facial swelling
asthma (wheezing)
shock

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

are age 60 or older
have had tomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children.

Do not use

if you are allergic to apirin or any other pain reliever/fever reducer
if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for epression, 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 its ingredients
in children under 12 years of age

Ask a doctor before use if

stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
you are taking a diuretic
you have
asthma
diabetes
thyroid disease
glaucoma
difficulty in urination due to enlargement of the prostate gland
a breathing problem such as emphysema or chronic bronchitis
a sodium-restricted diet

Ask a doctor or pharmacist before use if you are

taking a prescription drug for
gout
diabetes
arthrities
taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
you experience any of the following signs of stomach bleeding
feel faint
vomit blood
have bloody or black stools
have stomach pain that does not get better
pain or nasal congestion gets worse or lasts more than 7 days
fever gets worse or last more than 3 days
redness or swelling is present
new symptoms occur
ringing in the ears or a loss of hearing occurs
nervousness, dizziness, or sleeplessness occurs

If pregnant or breast-feeding,

ask a health professional before use.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In cae of overdose, get medical help or contact a Poion Control Center right away.

Directions

adults and children 12 years and over: take 2 tablets fully dissolved in 4 oz of water every 4 hours. Do not exceed 8 tablets in 24 hours or as directed by a doctor.
children under 12 years: do not use

Other information

each tablet contains: sodium 476 mg
Phenylketonurics: Contains Phenylalanine 8.4 mg Per Tablet
store at room temperature. Avoid excessive heat.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavor, mannitol, povidone, odium benzoate, sodium bicarbonate

Questions or comments?

1-800-986-0369 (Mon-Fri 9AM - 5PM EST)

Package Labeling:

INGREDIENTS AND APPEARANCE

ALKA SELTZER PLUS 1S BLISTER PACK

aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50269-151(NDC:0280-1400)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE BITARTRATE	7.8 mg

Ingredient Name	Strength
Inactive Ingredients
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
ASPARTAME (UNII: Z0H242BBR1)
CALCIUM SILICATE (UNII: S4255P4G5M)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MANNITOL (UNII: 3OWL53L36A)
POVIDONE (UNII: FZ989GH94E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor		Imprint Code	ALKA;SELTZER;PLUS
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:50269-151-00	6 in 1 BOX	10/30/2019
1		1 in 1 BLISTER PACK
1		2 in 1 POUCH; 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	10/30/2019

Labeler - JC World Bell Wholesale Co., Inc. (805257581)

Name	Address	ID/FEI	Business Operations
Establishment
JC World Bell Wholesale Co., Inc.		805257581	repack(50269-151)

Revised: 4/2022

Document Id: dc66b2fe-1c20-ad07-e053-2995a90a49f9

Set id: abb4a104-266b-4ce9-ab5f-5ee1760957e4

Version: 3

Effective Time: 20220411