Label: ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet
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- NDC Code(s): 71992-154-20
- Packager: Sincronia Logistica, S.A. de C.V.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated June 4, 2021
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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 ● 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
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INGREDIENTS AND APPEARANCE
ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71992-154 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength 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 Color white Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;DAY Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71992-154-20 20 in 1 CARTON; Type 0: Not a Combination Product 07/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/02/2018 Labeler - Sincronia Logistica, S.A. de C.V. (812799623)
