Label: ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS- acetaminophen, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit
- NDC Code(s): 0280-0099-01
- 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.
Drug Label Information
Updated March 13, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
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.
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
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
ingredients
● in children under 12 years of age
-
ASK DOCTOR
Ask a doctor before use if
liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes
● cough that occurs with excessive phlegm (mucus)
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
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
· 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
-
Directions
Directions
do not take more than the recommended dose
· do not take the Day and Night products at the same time; wait 4 hours
after the last Night dose before starting Day product.
· adults and children 12 years and over: take 2 capsules with water
every 4 hours. Do not exceed 6 capsules in 12 hours or as directed
by a doctor.
· children under 12 years: do not use
- OTHER SAFETY INFORMATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- QUESTIONS
- Package Display Label
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS COLD DAY AND NIGHT POWERMAX GELS
acetaminophen, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0099 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0099-01 1 in 1 CARTON; Type 0: Not a Combination Product 09/14/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 CAPSULE 12 Part 2 1 CAPSULE 4 Part 1 of 2 ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS, CONGESTION AND PAIN POWER MAX GELS
acetaminophen, dextromethorphan hydrobromide , phenylephrine hydrochloride capsule, liquid filledProduct Information Item Code (Source) NDC:0280-0095 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SODIUM HYDROXIDE (UNII: 55X04QC32I) GELATIN (UNII: 2G86QN327L) POVIDONE (UNII: FZ989GH94E) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) SORBITOL (UNII: 506T60A25R) SHELLAC (UNII: 46N107B71O) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange Score no score Shape OVAL Size 17mm Flavor Imprint Code ASP;CC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 BLISTER PACK 1 8 in 1 CAPSULE; 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 07/01/2021 Part 2 of 2 ALKA SELTZER PLUS MAXIMUM STRENGTH SINUS, ALLERGY AND COUGH POWER MAX GELS
acetaminophen, dextromethorphan hydrobromide , doxylamine succinate, phenylephrine hydrochloride capsule, liquid filledProduct Information Item Code (Source) NDC:0280-0097 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength SHELLAC (UNII: 46N107B71O) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) WATER (UNII: 059QF0KO0R) POTASSIUM ALUMINUM DISILICATE (UNII: SRB14JRX6C) SORBITAN (UNII: 6O92ICV9RU) SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color green Score no score Shape OVAL (Elliptical) Size 17mm Flavor Imprint Code ASP;N Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 2 in 1 BLISTER PACK 1 4 in 1 CAPSULE; 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 09/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2018 Labeler - Bayer HealthCare LLC. (112117283)