Alka-Seltzer Plus ® Cold Formula (Orange Zest)
Drug Labeling and Warnings
Drug Details [pdf]
ALKA-SELTZER PLUS COLD FORMULA (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.
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Alka-Seltzer Plus
® Cold
Formula (Orange Zest)
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
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, dimethylpolysiloxane, docusate sodium, FD&C red #40, FD&C yellow #6, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonate
PRINCIPAL DISPLAY PANEL - 26 Tablet Carton
BONUS 30% MORE
26 TABLETS FOR THE PRICE OF 20
Alka-
Seltzer
PLUS
®
Aspirin
(NSAID) / Pain reliever-
fever reducer Chlorpheniramine
maleate / Antihistamine Phenylephrine
bitartrate / Nasal decongestant
COLD
FORMULA
ORANGE ZEST
Nasal Congestion Runny Nose
Headache & Body Ache
Sore Throat Sinus Pressure
26 EFFERVESCENT TABLETS
| ALKA-SELTZER PLUS COLD
FORMULA (ORANGE ZEST)
aspirin, chlorpheniramine maleate, and phenylephrine bitartrate tablet, effervescent |
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| Labeler - Bayer HealthCare LLC. (112117283) |
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