ALKA-SELTZER PLUS SORE THROAT RELIEF HONEY LEMON FLAVOR- acetaminophen tablet, orally disintegrating 
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 Sore Throat Relief Honey Lemon Flavor

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever

Use For the temporary relief of sore throat pain.

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

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

ingredients

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop use and ask a doctor if

· pain gets worse or lasts more than 10 days

· fever gets worse or lasts more than 3 days

· redness or swelling is present

· new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

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

· do not take more than the recommended dose

· adults and children 12 years and over: take 2 tablets every 6 hours

while symptoms last

· place 1 tablet at a time on tongue. Allow the tablet to dissolve

completely before taking the second tablet. Water is not required.

· do not exceed 10 tablets in 24 hours or as directed by a doctor

· children under 12 years: do not use

Other information

Other information

Store at room temperature. Avoid excessive heat above 25°C (77°F)

Inactive ingredients citric acid, copovidone, crospovidone, FD&C Yellow #5 Aluminum Lake, flavors, gelatin, magnesium stearate, maltitol, mannitol, microcrystalline cellulose, mixture of transglutaminase and maltodextrin, pectin, polyphosphate, simethicone, sodium hexametaphosphate, sorbitol, sucralose

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

Honey Lemon package

ALKA-SELTZER PLUS SORE THROAT RELIEF HONEY LEMON FLAVOR 
acetaminophen tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0280-1207
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PECTIN (UNII: 89NA02M4RX)  
HEXASODIUM HEXAMETAPHOSPHATE (UNII: N40N91DW96)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
COPOVIDONE (UNII: D9C330MD8B)  
GELATIN (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTITOL (UNII: D65DG142WK)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SORBITOL (UNII: 506T60A25R)  
CROSPOVIDONE (UNII: 2S7830E561)  
FD&C YELLOW NO. 5 FREE ACID (UNII: 6TP696149N)  
MANNITOL (UNII: 3OWL53L36A)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize19mm
FlavorHONEYImprint Code Alka;Seltzer;PLUS;HONEY
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0280-1207-162 in 1 CARTON06/29/201707/01/2019
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/29/201707/01/2019
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 2/2018
 
Bayer HealthCare LLC.