Alka-Seltzer Plus Cold & Flu FizzyChews UI 1615333
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each tablet) Purposes
Acetaminophen 162.5 mg………….………...Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg……………………..……..Antihistamine
Dextromethorphan hydrobromide 5 mg…….………Cough suppressant
INDICATIONS & USAGE SECTION
Uses
· temporarily relieves these symptoms due to a cold or flu:
· minor aches and pains · headache · cough
· runny nose · sneezing · sore throat
· temporarily reduces fever
WARNINGS SECTION
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
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 SECTION
Do not use
● with any other drug containing acetaminophen (prescription or
nonprescription). If you are not sure whether a drug contains
acetaminophen, ask a doctor or pharmacist.
● 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 SECTION
Ask a doctor before use if you have
● liver 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 - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are
● taking the blood thinning drug warfarin
● taking sedatives or tranquilizers
OTC - WHEN USING SECTION
When using this product
● marked drowsiness may occur
● 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
OTC - STOP USE SECTION
Stop use and ask a doctor if
· 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
· cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms
Directions
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 tablets every 4 hours.
Do not exceed 12 tablets in 24 hours or as directed by a doctor.
· do not swallow tablets whole. Chew or crush tablets completely
before swallowing.
· children under 12 years: do not use
OTHER SAFETY INFORMATION
Other information
● each tablet contains: sodium 17 mg
● store at room temperature. Avoid excessive heat above 40 oC
(104 oF)
INACTIVE INGREDIENT SECTION
Inactive ingredients anhydrous citric acid, betadex,
carboxymethylcellulose, colloidal silicon dioxide, ethylcellulose, flavors,
magnesium searate, mannitol, microcrystalline cellulose, polyethylene,
sodium bicarbonate, sodium carbonate, sodium starch glycolate, stearic
acid, sucralose, xylitol
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Alka-Seltzer®
PLUS
Orange Flavor
Cold
& Flu
FIZZY CHEWS
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/ Cough Supressant
Phenylephrine Hydrochloride/Nasal Decongestant
ACTIVATES
WITHOUT
WATER
24 CHEWABLE TABLETS
- Cough
- Runny Nose
- Sneezing
- Fever & Body Ache
- Sore Throat