Label: ALKA-SELTZER PLUS NIGHT COLD MEDICINE- aspirin, doxylamine succinate, phenylephrine bitartrate and dextromethorphan hydrobromide tablet, effervescent
- NDC Code(s): 0280-1430-32
- Packager: Bayer HealthCare LLC, Consumer Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 16, 2010
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients (in each tablet) Purposes Aspirin 500 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Doxylamine succinate 6.25 mg Antihistamine Phenylephrine bitartrate 7.8 mg Nasal decongestant
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- sinus congestion and pressure
- sore throat
- nasal congestion
- runny nose
- temporarily reduces fever
- temporarily relieves these symptoms due to a cold:
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Aspirin may cause a severe allergic reaction which may include:
- facial swelling
- asthma (wheezing)
If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.
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
- 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.
- in children under 12 years of age
Ask a doctor before use if you have
- stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
- bleeding problems
- heart disease
- high blood pressure
- thyroid disease
- 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
- anticoagulation (blood thinning)
- 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 operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- 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
- ringing in the ears or loss of hearing occurs
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it 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.
- 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
- each tablet contains: sodium 474 mg
- Phenylketonurics: Contains Phenylalanine 5.6 mg per tablet
- store at room temperature. Avoid excessive heat.
- Inactive ingredients
acesulfame potassium, anhydrous citric acid, aspartame, calcium silicate, dimethylpolysiloxane, docusate sodium, flavors, mannitol, povidone, sodium benzoate, sodium bicarbonateClose
- Questions or comments?
1-800-986-0369 (Mon – Fri 9AM – 5PM EST) or www.alkaseltzerplus.comClose
- PRINCIPAL DISPLAY PANEL - Shipper Label
NIGHT COLD FORMULA
3200 TABLETS 1600 PIECES
1 00 16500 54213 8
STORE AT ROOM
AVOID EXCESSIVE HEAT
Bayer HealthCare LLC
P.O. Box 1910, Morristown, NJ
- INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS NIGHT COLD MEDICINE
aspirin, doxylamine succinate, phenylephrine bitartrate, and dextromethorphan hydrobromide tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1430 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 500 mg Doxylamine succinate (UNII: V9BI9B5YI2) (Doxylamine - UNII:95QB77JKPL) Doxylamine succinate 6.25 mg Phenylephrine bitartrate (UNII: 27O3Q5ML57) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine bitartrate 7.8 mg Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide 10 mg Product Characteristics Color WHITE Score no score Shape ROUND Size 26mm Flavor LEMON Imprint Code A;S;NT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-1430-32 1600 in 1 CASE 1 2 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/01/2010 Labeler - Bayer HealthCare LLC, Consumer Care (785159372)