Label: DAY-NIGHT SEVERE COLD AND FLU- day -acetaminophen, dextromethorhan hbr, guaifenesin, phenylephrine hcl night- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, kit
- NDC Code(s): 11822-3853-8, 11822-3854-9, 11822-8554-0
- Packager: RITE AID
- Category: HUMAN OTC DRUG LABEL
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 January 5, 2022
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- Official Label (Printer Friendly)
- DAYTIME COLD AND FLU
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion
- sinus congestion & pressure
- cough due to minor throat & bronchial irritation
- minor aches & pains
- headache
- fever
- sore throat
- 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.
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
• 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
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.
-
ASK DOCTOR
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• trouble urinating due to enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema - ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• 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. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- NIGHTTIME COLD & FLU
- ACTIVE INGREDIENT
- PURPOSE
-
INDICATIONS & USAGE
Uses
temporarily relieves common cold/flu symptoms:
• nasal congestion
• sinus congestion & pressure
• cough due to minor throat & bronchial irritation
• cough to help you sleep
• minor aches & pains
• headache
• fever
• sore throat
• runny nose & sneezing
• reduces swelling of nasal passages
• temporarily restores freer breathing through the nose
• promotes nasal and/or sinus drainage -
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
• more than 8 softgels in 24 hrs, which is the maximum daily amount for this product
• 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
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.
-
ASK DOCTOR
Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• thyroid disease
• diabetes
• glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
• trouble urinating due to enlarged prostate gland - ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
DAY-NIGHT SEVERE COLD AND FLU
day -acetaminophen, dextromethorhan hbr, guaifenesin, phenylephrine hcl night- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-8554 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-8554-0 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 08/03/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BLISTER PACK 16 Part 2 1 BLISTER PACK 8 Part 1 of 2 DAY SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorhan hbr, guaifenesin, phenylephrine hcl capsule, liquid filledProduct Information Item Code (Source) NDC:11822-3854 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 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 FD&C RED NO. 40 (UNII: WZB9127XOA) WATER (UNII: 059QF0KO0R) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) Product Characteristics Color orange Score no score Shape BULLET Size 16mm Flavor Imprint Code 73 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-3854-9 16 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 08/03/2020 Part 2 of 2 NIGHT SEVERE COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl, capsule, liquid filledProduct Information Item Code (Source) NDC:11822-3853 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 FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color green Score no score Shape BULLET Size 16mm Flavor Imprint Code 72 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-3853-8 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 08/03/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/03/2020 Labeler - RITE AID (014578892) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LTD 925822975 manufacture(11822-8554)