Label: DAYTIME NIGHTTIME COLD FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kit
- NDC Code(s): 11822-0851-4
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 7, 2024
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- Active ingredients for Daytime (in each softgel)
- Active ingredients for Nighttime (in each softgel)
- Purpose for Daytime
- Purpose for Nighttime
-
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
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 these products
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.
NIGHTTIME
Liver warning: This product 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
Alergy 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 following by fever, headache, rash, nausea, vomiting, consult a doctor promptly.
Do not use
DAYTIME
- 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.
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 an enlarged 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 tranquilizers
When using this product,
DAYTIME
do not exceed recommended dosage
NIGHTTIME
- do not exceed recommended dosage
- 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, and nasal congestion gets worse or lasts 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 signs of a serious condition.
NIGHTTIME
- pain 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 headache that lasts. These could be a signs of a serious condition.
Keep out of reach of children.
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 (1-800-222-1222) 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
DAYTIME
- 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
- adults and children 12 years and over; take 2 softgels with water every 4 hours.
- children under 12 years: do not use
NIGHTTIME
- 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
- 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?
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Principal Display Panel
Compare to the active ingredients in Vicks® DayQuil® and NyQuil® Cold & Flu LiquiCaps®
MULTI-SYMPTOM COLD & FLU RELIEF
DAYTIME
ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HBr 10 mg
PHENYLEPHRINE HCL 5 mg
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANT
NON-DROWSY
Temporarily relieves aches, fever & sore throat
Cough • Nasal congestion
Antihistamine-free
Alcohol-free
DAYTIME
SOFTGELS**
LIQUID FILLED CAPSULES
NIGHTTIME
ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HBr 15 mg
DOXYLAMINE SUCCINATE 6.25 mg
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT
ANTIHISTAMINE
Temporarily relieves aches, fever & sore throat
Cough,
Runny nose & sneezing
Alcohol-free
NIGHTTIME
SOFTGELS**
**LIQUID FILLED CAPSULES
†This product is not manufactured or distributed by The Procter & Gamble Company. Vicks®, DayQuil, NyQuil®, and LiquiCaps® 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 SHOW SIGNS OF TAMPERING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
DISTRIBUTED BY:
RITE AID
30 HUNTER LANE,
CAMP HILL, PA 17011
- Product Label
-
INGREDIENTS AND APPEARANCE
DAYTIME NIGHTTIME COLD FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0851 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0851-4 1 in 1 KIT; Type 0: Not a Combination Product 08/30/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 8 BLISTER PACK 8 Part 2 16 BLISTER PACK 16 Part 1 of 2 NIGHT TIME COLD AND FLU RELIEF MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate capsule, liquid filledProduct Information Item Code (Source) NDC:11822-3335 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 OVAL Size 20mm Flavor Imprint Code P30 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 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 Drug M012 08/30/2019 Part 2 of 2 DAYTIME COLD AND FLU NON DROWSY
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:11822-3391 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 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 Drug M012 08/30/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/30/2019 Labeler - Rite Aid Corporation (014578892)