Alka-Seltzer Plus Cold Orange Zest: Package Insert and Label Information

ALKA-SELTZER PLUS COLD ORANGE ZEST- aspirin, chlorpheniramine maleate and phenylephrine bitartrate tablet, effervescent
Bayer HealthCare LLC.

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.

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.

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

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 · 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 occur

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
● each tablet contains: sodium 476 mg
● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet

● store at room temperature. Avoid excessive heat.

Inactive ingredients acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate

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

ALka-

Seltzer®

PLUS

Cold

ORANGE ZEST

ASPIRIN (NSAID)/ Pain Reliever-Fever Reducer

Chlorpheniramine Maleate/Antihistamine

Phenylephrine Bitartrate/Nasal Decongestant

  • Nasal Congestion
  • Runny Nose
  • Sore Throat
  • Headache & Body Ache
  • Sinus Pressure

20 EFFERVESCENT TABLETS

Carton 20 count
(click image for full-size original)
ALKA-SELTZER PLUS COLD ORANGE ZEST
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
CHLORPHENIRAMINE MALEATE (CHLORPHENIRAMINE) CHLORPHENIRAMINE MALEATE 2 mg
PHENYLEPHRINE BITARTRATE (PHENYLEPHRINE) PHENYLEPHRINE BITARTRATE 7.8 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS CITRIC ACID
CALCIUM SILICATE
FD&C RED NO. 40
SODIUM BENZOATE
ACESULFAME POTASSIUM
DIMETHICONE
FD&C YELLOW NO. 6
DOCUSATE SODIUM
MANNITOL
POVIDONE
SODIUM BICARBONATE
Product Characteristics
Color white (White with orange and black flecks) Score no score
Shape ROUND Size 25mm
Flavor ORANGE Imprint Code Alka;Seltzer
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0280-1510-20 10 POUCH in 1 CARTON contains a POUCH
1 2 TABLET, EFFERVESCENT in 1 POUCH This package is contained within the CARTON (0280-1510-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 07/15/2017
Labeler — Bayer HealthCare LLC. (112117283)

Revised: 11/2019 Bayer HealthCare LLC.

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