ALKA SELTZER PLUS COLD- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Alka Seltzer Plus Cold by

Drug Labeling and Warnings

Alka Seltzer Plus Cold by is a Otc medication manufactured, distributed, or labeled by Navajo Manufacturing Company Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 symptoms 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 stomach 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 aspirin or any other pain reliever/fever reducer
 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.
 in children under 12 years of age

if you have had a allergic reaction to this product or any of its ingredients

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  arthritis  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 lasts 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,

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 case of overdose, get medical help or contact a Poison 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

do not use if pouch is opened each tablet contains: sodium 474 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, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions or comments?

1-800-986-0369 (Mon - Fri 9AM - 5PM EST) or www.alkaseltzerplus.com

Package Labeling:

INGREDIENTS AND APPEARANCE

ALKA SELTZER PLUS COLD 
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67751-142(NDC:0280-1400)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67751-142-01	1 in 1 CARTON	09/17/2016
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 67751-142-02	1 in 1 CARTON	09/17/2016
2		4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	09/17/2016

Labeler - Navajo Manufacturing Company Inc. (091917799)

Establishment
Name	Address	ID/FEI	Business Operations
Navajo Manufacturing Company Inc.		136941411	relabel(67751-142) , repack(67751-142)