![ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET [SINCRONIA LOGISTICA, S.A. DE C.V.]](https://medic.hrt.org//dailymed/images/c478df69-823a-4112-8f44-323249a9f38f/Inner Package.jpg)
![ALKA SELTZER PLUS COLD DAY AND NIGHT EFFERVESCENT (ASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE) TABLET [SINCRONIA LOGISTICA, S.A. DE C.V.]](https://medic.hrt.org//dailymed/images/c478df69-823a-4112-8f44-323249a9f38f/Outer Package.jpg)
| NDC | 71992-154-20 |
| Set ID | c478df69-823a-4112-8f44-323249a9f38f |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Sincronia Logistica, S.A. de C.V. |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist |
| Product Number | |
| Application Number | PART341 |
- Drug Facts
- Active ingredients (in each tablet)
- Uses
-
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
- Directions
- Other information
- Inactive ingredients
- Questions?
- Package Labeling:
-
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)
