Label: ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS, ALLERGY AND COUGH- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
- NDC Code(s): 0280-1620-20
- Packager: Bayer HealthCare LLC.
- 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.
Updated November 4, 2019
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
· temporarily relieves these symptoms due to hay fever or other upper
· runny nose · sneezing
· itching of the nose or throat · itchy, watery eyes
· temporarily relieves these symptoms due to a cold:
· nasal congestion · sinus congestion and pressure
· headache · minor aches and pains · cough
· temporarily reduces fever
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.
Do not use to sedate children.
DO NOT USE
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 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
● in children under 12 years of age
Ask a doctor before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes ● glaucoma
● 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,
- ASK DOCTOR/PHARMACIST
- WHEN USING
Stop use and ask a doctor if
· pain, cough, or nasal congestion gets worse or lasts more than
· fever gets worse or lasts more than 3 days
· redness or swelling is present
· new symptoms occur
· cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition.
· nervousness, dizziness, or sleeplessness occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Other information
- INACTIVE INGREDIENT
- Questions or Comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS MAXIMUM STRENGTH SEVERE SINUS, ALLERGY AND COUGH
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-1620 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SORBITOL (UNII: 506T60A25R) SORBITAN (UNII: 6O92ICV9RU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color green Score no score Shape OVAL Size 20mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-1620-20 2 in 1 CARTON 06/26/2017 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/26/2017 Labeler - Bayer HealthCare LLC. (112117283)