Label: MULTI SYMPTON COLD DAY NIGHT- acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kit
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Contains inactivated NDC Code(s)
NDC Code(s): 67510-0156-2, 67510-1156-1, 67510-2156-1, 67510-3156-1, view more67510-4156-1, 67510-9156-0 - Packager: Kareway Product, Inc.
- 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 February 16, 2013
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients for Night(in each tablet)
- Active ingredients for Day(in each tablet)
- Purpose for Night
- Purpose for Day
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Uses
- temporarily relieves these common cold symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- cough
- sneezing and runny nose (Night only)
- sinus congestion and pressure (Day only)
- helps clear nasal passages
- relieves cough to help you sleep (Night only)
- promotes nasal and sinus drainage (Day only)
- temporarily reduces fever
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Warnings
Alcohol warning:If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers or fever reducers. Acetaminophen may cause liver damage.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
- with any other product containing acetaminophen
- 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 you prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis (Night only)
- glaucoma (Night only)
Ask a doctor or pharmacist before use if you are (Night only)
taking sedatives or tranquilizers (Night only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Night only)
- marked drowsiness may occur (Night only)
- alcohol, sedatives and tranquilizers may increase drowsiness (Night only)
- avoid alcoholic drinks (Night only)
- be careful when driving a motor vehicle or operating machinery (Night only)
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion or cough 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.
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Directions
- do not take more than directed (see overdose warning)
adults and children 12 years and over
- take 2 tablets every 4 hours
- swallow whole - do not crush, chew or dissolve
- do not take more than 12 tablets in 24 hours
children under 12 years
Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
- Other information
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Inactive ingredients
microcrystalline cellulose, lactose, hydroxypropyl cellulose, sodium starch glycolate, sillicon dioxide, magnesium stearate, hypromellose (Night only), bleu no.1 (Night only), titanium dioxide (Night only), polyethylene glycol (Night only), anhydrous citric acid, sodium citrate, ethanol, FDC Yellow no.5 (Day only),
- Package label
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INGREDIENTS AND APPEARANCE
MULTI SYMPTON COLD DAY NIGHT
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-0156 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-0156-2 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 12 Part 2 1 BLISTER PACK 12 Part 1 of 2 MULTI SYMPTOM NIGHT
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tabletProduct Information Item Code (Source) NDC:67510-1156 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color blue (light blue) Score no score Shape ROUND Size 9mm Flavor Imprint Code MS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-1156-1 1 in 1 BOX 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2012 Part 2 of 2 MULTI SYMPTON DAY NON DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tabletProduct Information Item Code (Source) NDC:67510-2156 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white (white) Score no score Shape ROUND Size 9mm Flavor Imprint Code MS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-2156-1 1 in 1 BOX 1 12 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2012 MULTI SYMPTON COLD DAY NIGHT
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67510-9156 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-9156-0 1 in 1 PACKAGE, COMBINATION Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 10 Part 2 1 BLISTER PACK 10 Part 1 of 2 MULTI SYMPTOM NIGHT
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl tabletProduct Information Item Code (Source) NDC:67510-3156 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color blue (light blue) Score no score Shape ROUND Size 9mm Flavor Imprint Code MS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-3156-1 1 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2012 Part 2 of 2 MULTI SYMPTON DAY NON DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl tabletProduct Information Item Code (Source) NDC:67510-4156 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM CITRATE (UNII: 1Q73Q2JULR) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color white (white) Score no score Shape ROUND Size 9mm Flavor Imprint Code MS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67510-4156-1 1 in 1 BOX 1 10 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 05/01/2012 Labeler - Kareway Product, Inc. (121840057)