Label: DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 41250-653-48
- Packager: MEIJER, 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 November 1, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients in Daytime (in each softgel)
- Active ingredients in Nighttime (in each softgel)
- Purpose for Daytime
- Purpose for Nighttime
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Uses
DAYTIME
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- nasal congestion
- headache
- minor aches and pains
- fever
- sore throat
NIGHTTIME
- temporarily relieves common cold and flu symptoms
- cough due to minor throat and bronchial irritation
- sore throat
- headache
- minor aches and pains
- fever
- runny nose and sneezing
- temporarily relieves common cold and flu symptoms
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Warnings
DAYTIME and NIGHTTIME
Liver warning: These products contain 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:
- 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
DAYTIME and NIGHTTIME
- 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.
Ask a doctor before use if you have
DAYTIME
- liver disease
- heart disease
- diabetes
- thyroid disease
- high blood pressure
- cough that occurs with too much phlegm (mucus)
- trouble urinating due to an enlarged prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
NIGHTTIME
- liver disease
- glaucoma
- cough that occurs with too much phlegm (mucus)
- a breathing problem or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- trouble urinating due to ananlarged prostate gland
Ask a doctor or pharmacist before use if you are
DAYTIME
taking the blood thinning drug warfarin.
NIGHTTIME
- taking the blood thinning drug warfarin
- taking sedatives or tranquillizers
When using this product,
DAYTIME
do not exceed recommended dosage.
NIGHTTIME
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
DAYTIME
- nervousness, dizziness, or sleeplessness occur
- pain, cough, or nasal congestion gets worse or last more than 7 days
- redness or swelling is present
- new symptoms occur
- fever gets worse or lasts more than 3 days
- cough comes back or occurs with rash or headache that lasts. These could be sighs of a serious condition.
NIGHTTIME
- pain or cough gets worse or last 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.
DAYTIME and NIGHTTIME
Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
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Directions
- do not take more than directed (see Overdose warning )
- do not take more than 4 doses in 24 hours
- swallow whole; do not crush, chew, or dissolve
Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours
Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours
- children under 12 years: do not use
- Other information
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Inactive ingredients
Daytime butylated hydroxyanisole, butylated hydroxytoluene, FD&C yellow #6*, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol white ink
Nighttime D&C yellow #10, FD&C blue #1, gelatin, glycerin, mannitol, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol, white ink
- Questions or comments?
-
Principal Display Panel
DAYTIME
Compare to Vicks® DayQuil® LiquiCap® active ingredients†
Non-Drowsy
DayTime Cold and Flu
Acetaminophen | 325 mg Pain reliever / Fever reducer
Dextromethorphan HBr | 10 mg Cough suppressant
Phenylephrine HCL | 5 mg Nasal decongestant
RELIEF OF:
Aches; Fever; Sore Throat; Cough; Nasal Congestion
Alcohol-free
Antihistamine-free
Softgels**
(Liquid-filled Capsules
NIGHTTIME
Compare to Vicks® Nyquil® LiquiCap® active ingredients†
NiteTime COLD & FLU
Acetaminophen | 325 mg Pain reliever / Fever reducer
Dextromethorphan HBr | 15 mg Cough suppressant
Doxylamine succinate | 6.25 mg Antihistamine
RELIEF OF:
Aches; Fever; Sore Throat; Cough; Sneezing; Runny Nose
Softgels**
(Liquid-filled Capsules)
When using Daytime and Nighttime products, carefully read the labeling to ensure correct dosing.
†This product is not manufactured or distributed by the Procter & Gamble Company. Vick®, DayQuil®. NyQuil®, and LiquiCap® are registered trademarks of the Procter and Gamble Company.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD AND FLU RELIEF MULTI-SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-653 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-653-48 1 in 1 KIT; Type 0: Not a Combination Product 11/29/2019 05/30/2025 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 BLISTER PACK 16 Part 2 32 BLISTER PACK 32 Part 1 of 2 NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate capsuleProduct 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 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color green Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P30 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16 in 1 CARTON 1 1 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 11/29/2019 05/30/2025 Part 2 of 2 DAYTIME COLD AND FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsuleProduct 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITAN (UNII: 6O92ICV9RU) SORBITOL (UNII: 506T60A25R) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color orange Score no score Shape CAPSULE Size 20mm Flavor Imprint Code P19 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 32 in 1 CARTON 1 1 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 11/29/2019 05/30/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/29/2019 05/30/2025 Labeler - MEIJER, INC. (006959555)
