FDA Label for Alka-seltzer Plus Cold And Cough
View Indications, Usage & Precautions
- OTHER
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - WHEN USING
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS OR COMMENTS?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-seltzer Plus Cold And Cough Product Label
The following document was submitted to the FDA by the labeler of this product Bayer Healthcare Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Active Ingredient
Active ingredients (in each tablet)
Aspirin 325 mg (NSAID)*
Chlorpheniramine maleate 2 mg
Dextromethorphan hydrobromide 10 mg
Phenylephrine bitartrate 7.8 mg
*nonsteroidal anti-inflammatory drug
Otc - Purpose
Purposes
Pain reliever/fever reducer
Antihistamine
Cough suppressant
Nasal decongestant
Uses
Uses
temporarily relieves these symptoms due to a cold with cough:
·minor aches and pains ·headache ·cough
·runny nose ·nasal and sinus congestion
·sneezing ·sore throat
·temporarily reduces fever
Warnings
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.
Otc - Do Not Use
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
Otc - Ask Doctor
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
● cough with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium-restricted diet
Otc - When Using
When using this product
● do not exceed recommended dosage
may cause marked drowsiness
● avoid alcoholic drinks
● excitability may occur, especially in children
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
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, cough, 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
cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
nervousness, dizziness, or sleeplessness occurs
Otc - 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.
Otc - 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.
Directions
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
Other information
● each tablet contains: sodium 416 mg
● Phenylketonurics: Contains Phenylalanine 9 mg Per Tablet
● store at room temperature. Avoid excessive heat.
Inactive Ingredient
Inactive ingredients acesulfame potassium, anhydrous citric
acid, aspartame, calcium silicate, dimethicone, docusate sodium, FD&C
red #40, flavors, mannitol, povidone, sodium benzoate, sodium
bicarbonate
Questions Or Comments?
Questions or comments?1-800-986-0369 (Mon - Fri 9AM -
5PM EST)
Package Label.Principal Display Panel
Alka-Seltzer
PLUS®
Cold &
Cough
CITRUS
ASPIRIN (NSAID) / Pain Reliever/Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppresant
Phenylephrine Bitartrate/Nasal Decongestant
- Cough
- Nasal Congestion
- Runny Nose
- Headache & Body Ache
- Sinus Pressure
20 EFFERVESCENT TABLETS
* Please review the disclaimer below.