Label: SEVERE COLD AND FLU PLUS CONGESTION- acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kit
- NDC Code(s): 63981-795-81
- Packager: COSTCO WHOLESALE CORPORATION
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 5, 2024
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-
Day
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- nasal congestion
- sore throat
- minor aches and pains
- headache
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- reduces swelling of nasal passages
- temporarily reduces fever
- temporarily restores freer breathing through the nose
- promotes nasal and/or sinus drainage
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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 reactions. Symptoms may include:
- blisters
- rash
- skin reddening
If a skin 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
- 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
Ask a doctor before use if you have
- liver disease
- diabetes
- thyroid disease
- heart disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- redness or swelling is present
- new symptoms occur
- pain, nasal congestion, or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Directions
- do not take more than directed
- do not take more than 8 caplets in 24 hours
- adults and children 12 years and over: take 2 caplets with water every 4 hours
- children under 12 years: ask a doctor
Other information
- each caplet contains: sodium 3 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
benzyl alcohol, corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
- temporarily relieves common cold and flu symptoms:
-
Night
Active ingredients (in each caplet)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- nasal congestion
- sore throat
- minor aches and pains
- headache
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- cough to help you sleep
- runny nose and sneezing
- reduces swelling of nasal passages
- temporarily reduces fever
- promotes nasal and/or sinus drainage
- temporarily restores freer breathing through the nose
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 reactions. Symptoms may include:
- blisters
- rash
- skin reddening
If a skin 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
- 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
Ask a doctor before use if you have
- liver disease
- diabetes
- heart disease
- thyroid disease
- high blood pressure
- glaucoma
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
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.
Directions
- do not take more than directed
- do not take more than 8 caplets in 24 hours
- adults and children 12 years and over: take 2 caplets with water every 4 hours
- children under 12 years: ask a doctor
Other information
- each caplet contains: sodium 3 mg
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- see end flap for expiration date and lot number
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
Inactive ingredients
benzyl alcohol, black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, propylene glycol, silicon dioxide, sodium starch glycolate, stearic acid, sucralose, talc, titanium dioxide
- temporarily relieves common cold and flu symptoms:
-
Principal display panel
KIRKLAND
SignatureCOMPARE TO VICKS® DAYQUIL® & NYQUIL® VAPOCOOL®
SEVERE COLD & FLU + CONGESTION
active ingredients*NDC 63981-795-81
ITM. / ART. 1729556COOL BLAST
SEVERE COLD & FLU
PLUS CONGESTIONAcetaminophen 325 mg,
Dextromethorphan HBr 10 mg, Guaifenesin 200 mg,
Phenylephrine HCl 5 mgPain Reliever • Fever Reducer • Cough Suppressant
Expectorant • Nasal DecongestantRelieves:
Headache, Fever, Sore Throat,
Minor Aches & Pains
Chest Congestion, Thins &
Loosens Mucus
Nasal Congestion, Sinus Pressure
CoughActual
Size112 DAY COATED CAPLETS
Acetaminophen 325 mg,
Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg,
Phenylephrine HCl 5 mgPain Reliever • Fever Reducer • Cough Suppressant
Antihistamine • Nasal DecongestantRelieves:
Headache, Fever, Sore Throat,
Minor Aches & Pains
Nasal Congestion,
Sinus Pressure
Sneezing, Runny Nose
CoughActual
Size56 NIGHT COATED CAPLETS
168
TOTAL CAPLETSTAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGDo Not Take Daytime and Nighttime Products at the Same Time.
*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the
registered trademark Vicks® DayQuil® and NyQuil® VapoCOOL® Severe Cold & Flu + Congestion.
50844 REV0223A79579681Manufactured by: LNK INTERNATIONAL, INC.
60 Arkay Drive, Hauppauge, NY 11788 USA
For: Costco Wholesale Corporation
999 Lake Drive, Issaquah, WA 98027 USA
www.costco.com23V08014a
Kirkland 44-795796
-
INGREDIENTS AND APPEARANCE
SEVERE COLD AND FLU PLUS CONGESTION
acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63981-795 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63981-795-81 14 in 1 CARTON 06/30/2023 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 Part 2 4 Part 1 of 2 SEVERE COLD AND FLU PLUS CONGESTION DAY
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:63981-995 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 GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C RED NO. 40 ALUMINUM LAKE (UNII: 6T47AS764T) FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color orange Score no score Shape OVAL Size 19mm Flavor MENTHOL Imprint Code 44;795 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/30/2023 Part 2 of 2 SEVERE COLD AND FLU PLUS CONGESTION NIGHT
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:63981-996 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 BENZYL ALCOHOL (UNII: LKG8494WBH) FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C YELLOW NO. 6 ALUMINUM LAKE (UNII: GYP6Z2JR6Q) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 19mm Flavor MENTHOL Imprint Code 44;796 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/30/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/30/2023 Labeler - COSTCO WHOLESALE CORPORATION (103391843) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(63981-795) , pack(63981-795) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(63981-795) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(63981-795) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(63981-795)