NDC | 11673-649-22 |
Set ID | 0f7698bb-de3c-487b-8070-c319854bf7a7 |
Category | HUMAN OTC DRUG LABEL |
Packager | Target Corporation |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each caplet) (Daytime Severe Cold & Flu)
- Purpose
- Active ingredients (in each caplet)(Nighttime Severe Cold & Flu)
- Purpose
-
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- nasal congestion
- headache
- fever
- sore throat
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- runny nose and sneezing (Nighttime only)
- reduces swelling of nasal passages
- 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 (Daytime only)
- temporarily relieves common cold and flu symptoms:
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
- more than 4,000 mg of acetaminophen in 24 hours
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:- skin reddening
- blisters
- rash
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
- high blood pressure
- glaucoma (Nighttime only)
- thyroid disease
- heart disease
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
- 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 (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- be careful when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
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.
Keep out of reach of children
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing.
- Directions
- Other information
- Inactive ingredients (Daytime only)
-
Inactive ingredients (Nighttime only)
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
- Questions or comments?
-
Principal Display Panel
Compare to active ingredients in
Vicks® DayQuil® Severe Cold & Flu*MAX
STRENGTHDaytime
severe cold and fluacetaminophen
(pain reliever / fever reducer)
dextromethorphan HBr (cough suppressant)
guaifenesin (expectorant)
phenylephrine HCl (nasal decongestant)aches, fever and sore throat
chest congestion and cough
nasal congestionup & up™
ACTUAL SIZE
32 CAPLETS
NDC 11673-649-22
Compare to active ingredients in
Vicks® NQuil® Severe Cold & Flu*MAX
STRENGTHnighttime
severe cold and fluacetaminophen
(pain reliever / fever reducer)
dextromethorphan HBr (cough suppressant)
doxylamine succinate (antihistamine)
phenylephrine HCl (nasal decongestant)aches, fever and sore throat
nasal congestion and cough
sneezing and runny noseup & up™
ACTUAL SIZE
16 CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks® DayQuil® Severe Cold & Flu and Vicks® NyQuil® Severe Cold & Flu.
50844 REV0417A64067722
Distributed by Target Corporation
Minneapolis, MN 55403
© 2017 Target Brands, Inc.Target 44-640677
-
INGREDIENTS AND APPEARANCE
SEVERE COLD AND FLU DAYTIME/NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11673-649 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11673-649-22 1 in 1 CARTON; Type 0: Not a Combination Product 08/01/2015 10/02/2022 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 4 BLISTER PACK 32 Part 2 2 BLISTER PACK 16 Part 1 of 2 SEVERE COLD AND FLU DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information 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 STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color ORANGE Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;640 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 02/27/2014 Part 2 of 2 SEVERE COLD AND FLU NIGHTTIME
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coatedProduct Information 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) Product Characteristics Color GREEN Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;677 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 08/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 08/01/2015 10/02/2022 Labeler - Target Corporation (006961700) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 038154464 PACK(11673-649) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 MANUFACTURE(11673-649) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 PACK(11673-649) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 967626305 PACK(11673-649) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 PACK(11673-649)