Label: MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME- acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate kit
- NDC Code(s): 11822-1988-0, 11822-1988-9
- Packager: RITE AID
- 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 December 26, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- wtth other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
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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.
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ASK DOCTOR
Ask a doctor before use if you have
- liver disease
- glaucoma (nighttime only)
- heart disease (Daytime only)
- high blood pressure (Daytime only)
- thyroid disease (Daytime only)
- diabetes (Daytime only)
- 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, or emphysema (Daytime only)
- a breathing problem or chronic cough that lasts or as occurs wtth smoking, asthma, chronic bronchitis or emphysema (nighttime only)
- ASK DOCTOR/PHARMACIST
-
WHEN USING
When using this product, do not use more than directed.(daytime only)
- excitability may occur, especially in children (nighttime only)
- marked drowsiness may occur (nighttime only)
- avoid alcoholic drinks (nighttime only)
- be carefull when driving a motor vehicle or operating machinery. (nighttime only)
- alcohol, sedatives, & tranquilizers may increase drowsiness. (nighttime only)
-
STOP USE
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless (daytime only)
- pain, nasal congestion or cough get worse or last more than 7 days (daytime only)
- pain or cough gets worse or lasts more than 7 days (nighttime only)
- 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
Directions
- take only as directed
- do not exceed 4 doses per 24 hours
adults & children 12 yrs & over: 2 softgels with water every 4 hrs (daytime only)
adults & children 12 yrs & over: 2 softgels with water every 6 hrs (nighttime only)
children 4 to under 12 yrs:ask a doctor
children under 4 yrs:do not use - OTHER INFORMATION
-
INACTIVE INGREDIENT
daytime cold & flu
Inactive ingredients FD&C red#40, FD&C yellow#6, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxidenighttime cold & flu
Inactive ingredients FD&C blue#1, D&C yellow#10, gelatin, glycerin, polyethylene glycol,
povidone, propylene glycol, purified water, shellac, sorbitol sorbitan solution, titanium dioxide - QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME NIGHTTIME
acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-1988 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-1988-0 2 in 1 CARTON 09/15/2021 1 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:11822-1988-9 4 in 1 CARTON 09/15/2021 2 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 Part 2 8 Part 1 of 2 MULTI-SYMPTOM COLD AND FLU RELIEF DAYTIME
acetaminophen 325 mg dextromethorphan hbr 10 mg phenylephrine hci 5 mg capsule, liquid filledProduct Information Item Code (Source) NDC:11822-1989 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 PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SORBITAN (UNII: 6O92ICV9RU) SHELLAC (UNII: 46N107B71O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color orange Score no score Shape OVAL (OBLONG SHAPED) Size 21mm Flavor Imprint Code 70 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/15/2021 Part 2 of 2 MULTI-SYMPTOM COLD AND FLU RELIEF NIGHTTIME
acetaminophen 325 mg dextromethorphan hbr 15 mg doxylamine succinate 6.25 mg capsule, liquid filledProduct Information Item Code (Source) NDC:11822-1987 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg Inactive Ingredients Ingredient Name Strength SORBITAN (UNII: 6O92ICV9RU) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color green Score no score Shape OVAL Size 21mm Flavor Imprint Code 71 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/15/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 09/15/2021 Labeler - RITE AID (014578892) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(11822-1988)