ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet 
Sincronia Logistica, S.A. de C.V.

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ALKA-SELTZER PLUS Cold Day & Night Effervescent

Drug Facts

Active ingredients (in each tablet)

Aspirin 325 mg (NSAID)*

Dextromethorphan hydrobromide 10 mg

Phenylephrine bitartrate 7.8 mg

*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Uses

• temporarily relieves these symptoms due to a cold:

• minor aches and pains • headache • runny nose

• sinus congestion and pressure • cough • sneezing • sore throat

• nasal congestion • temporarily reduces fever

Warnings

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. Reye’s syndrome:

Aspirin may cause a severe allergic reaction which may include: Allergy alert:

● hives ● facial swelling ● asthma (wheezing) ● shock

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:

● 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

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. Sore throat warning:

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 ● thyroid disease ● diabetes

● 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

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

● may cause marked drowsiness 

● avoid alcoholic drinks

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or 

● 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 at bedtime (may be taken every 4 to 6 hours). Do not exceed 8 tablets in 24 hours or as directed by a doctor. ● children under 12 years: do not use

Other information

sodium 476 mg ● Phenylketonurics: Contains Phenylalanine 5.6 mg Per Tablet

● each tablet contains:

● store at room temperature. Avoid excessive heat.

Inactive ingredients

acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethicone, docusate sodium, flavors (natural & artificial), mannitol, povidone, sodium benzoate, sodium bicarbonate

Questions?

1-800-986-0369 

Package Labeling:

Outer PackageInner Package

ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT 
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71992-154
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE7.8 mg
Inactive Ingredients
Ingredient NameStrength
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
ASPARTAME (UNII: Z0H242BBR1)  
CALCIUM SILICATE (UNII: S4255P4G5M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DOCUSATE SODIUM (UNII: F05Q2T2JA0)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
MANNITOL (UNII: 3OWL53L36A)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize25mm
FlavorCITRUSImprint Code ASP;DAY
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71992-154-2020 in 1 CARTON; Type 0: Not a Combination Product07/02/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01207/02/2018
Labeler - Sincronia Logistica, S.A. de C.V. (812799623)

Revised: 10/2023
Document Id: 086318bd-5067-477e-e063-6294a90ab2dd
Set id: c478df69-823a-4112-8f44-323249a9f38f
Version: 4
Effective Time: 20231023
 
Sincronia Logistica, S.A. de C.V.