ALKA-SELTZER LEMON LIME tablet, effervescent

Alka-Seltzer Original Flavor by

Drug Labeling and Warnings

Alka-Seltzer Original Flavor by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Anhydrous citric acid 1000 mg.................................………Antacid

Aspirin 325 mg (NSAID) 1…………………….……………Analgesic

Sodium bicarbonate (heat-treated) 1700 mg.……………..Antacid

1 nonsteroidal anti-inflammatory drug

PURPOSE

Anhydrous citric acid 1000 mg............................ Antacid

Aspirin 325 mg (NSAID)*.................................Analgesic
Sodium bicarbonate (heat-treated) 1700 mg...... Antacid
*nonsteroidal anti-inflammatory drug

INDICATIONS & USAGE

for the temporary relief of

● heartburn, acid indigestion, and sour stomach when

accompanied with headache or body aches and pains

● upset stomach with headache from overindulgence in

food or drink

● pain alone (headache or body and muscular aches and pains)

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

DO NOT USE

Do not use
● if you are allergic to aspirin or any other pain reliever/fever
reducer

● if you have ever had an allergic reaction to this product or any

of its ingredients

ASK DOCTOR

● 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

● you have a sodium-restricted diet

ASK DOCTOR/PHARMACIST

● presently taking a prescription drug. Antacids may

interact with certain prescription drugs.

● taking a prescription drug for diabetes, gout, or arthritis

WHEN USING

When using this product do not exceed recommended dosage

STOP USE

● 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

● symptoms get worse or last more than 10 days

● redness or swelling is present

● ringing in the ears or a loss of hearing occurs

● new symptoms occur

PREGNANCY 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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

● fully dissolve 2 tablets in 4 ounces of water before taking

adults and children 12 years and over	2 tablets every 4 hours, or as directed by a doctor	do not exceed 8 tablets in 24hours
adults 60 years and over	2 tablets every 4 hours, or as directed by a doctor	do not exceed 4 tablets in 24 hours
children under 12 years	consult a doctor	consult a doctor

OTHER SAFETY INFORMATION

● each tablet contains: sodium 504 mg

● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat.

● Alka-Seltzer Lemon Lime in water contains principally the

antacid sodium citrate and the analgesic sodium

acetylsalicylate

INACTIVE INGREDIENT

aspartame, docusate sodium, flavor, povidone, sodium benzoate

QUESTIONS

Questions or comments?1-800-986-0369 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL

Alka-Seltzer

Anhydrous citric acid / Antacid
Aspirin (NSAID) / Analgesic
Sodium bicarbonate / Antacid
36 EFFERVESCENT TABLETS
Fast Relief of:
Heartburn
Upset Stomach
Acid Indigestion
with Headache
Body Aches
LEMON LIME

36 EFFERVESCENT TABLETS

INGREDIENTS AND APPEARANCE

ALKA-SELTZER LEMON LIME 
alka-seltzer lemon lime tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0280-4020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)	ANHYDROUS CITRIC ACID	1000 mg
SODIUM BICARBONATE (UNII: 8MDF5V39QO) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM BICARBONATE	1700 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
ASPARTAME (UNII: Z0H242BBR1)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
POVIDONE (UNII: FZ989GH94E)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	25mm
Flavor	LEMON	Imprint Code	Alka;Seltzer;Antacid
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0280-4020-36	18 in 1 CARTON	11/07/2014
1		2 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	11/07/2014

Labeler - Bayer HealthCare LLC. (112117283)