NDC 11822-1988 Multi-symptom Cold And Flu Relief Daytime Nighttime
Acetaminophen Dextromethorphan Hbr Phenylephrine Hcl And Acetominophen Dextromethorphan Hb...
Product Information
What is NDC 11822-1988?
The NDC code 11822-1988 is assigned by the FDA to the product Multi-symptom Cold And Flu Relief Daytime Nighttime which is a human over the counter drug product labeled by Rite Aid. The generic name of Multi-symptom Cold And Flu Relief Daytime Nighttime is acetaminophen dextromethorphan hbr phenylephrine hcl and acetominophen dextromethorphan hbr doxylamine succinate. The product's dosage form is kit. The product is distributed in 2 packages with assigned NDC codes 11822-1988-0 2 blister pack in 1 carton / 1 kit in 1 blister pack, 11822-1988-9 4 blister pack in 1 carton / 1 kit in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.
What are the uses for Multi-symptom Cold And Flu Relief Daytime Nighttime?
Uses temporarily relieves common cold/flu symptoms: nasal congestion (Daytime only)cough due to minor throat & bronchial irritationsore throatheadacheminor aches & painsfeverrunny nose & sneezing (Nithttime only)
Product Characteristics
Color(s) | GREEN (C48329) ORANGE (C48331) |
Shape | OVAL (C48345) |
Size(s) | 21 MM |
Imprint(s) | 71 70 |
Score | 1 |
Product Packages
NDC Code 11822-1988-0
Package Description: 2 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
NDC Code 11822-1988-9
Package Description: 4 BLISTER PACK in 1 CARTON / 1 KIT in 1 BLISTER PACK
Product Details
Multi-symptom Cold And Flu Relief Daytime Nighttime Active Ingredients UNII Codes
- DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2)
- DOXYLAMINE (UNII: 95QB77JKPL) (Active Moiety)
- ACETAMINOPHEN (UNII: 362O9ITL9D)
- ACETAMINOPHEN (UNII: 362O9ITL9D) (Active Moiety)
- DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH)
- DEXTROMETHORPHAN (UNII: 7355X3ROTS) (Active Moiety)
- PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ)
- PHENYLEPHRINE (UNII: 1WS297W6MV) (Active Moiety)
NDC to RxNorm Crosswalk
- RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule
- RxCUI: 1086997 - acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
- RxCUI: 1086997 - APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule
- RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule
- RxCUI: 1094549 - acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule
Multi-symptom Cold And Flu Relief Daytime Nighttime Inactive Ingredients UNII Codes
- 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)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
* Please review the disclaimer below.
Patient Education
Acetaminophen
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]
Dextromethorphan
Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]
Doxylamine
Doxylamine is used in the short-term treatment of insomnia (difficulty falling asleep or staying asleep). Doxylamine is also used in combination with decongestants and other medications to relieve sneezing, runny nose, and nasal congestion caused by the common cold. Doxylamine should not be used to cause sleepiness in children. Doxylamine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.
[Learn More]
Phenylephrine
Phenylephrine is used to relieve nasal discomfort caused by colds, allergies, and hay fever. It is also used to relieve sinus congestion and pressure. Phenylephrine will relieve symptoms but will not treat the cause of the symptoms or speed recovery. Phenylephrine is in a class of medications called nasal decongestants. It works by reducing swelling of the blood vessels in the nasal passages.
[Learn More]
* Please review the disclaimer below.
Multi-symptom Cold And Flu Relief Daytime Nighttime Product Label
FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Product Label Table of Contents
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Otc - Active Ingredient
daytime cold &flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg
nighttime cold &flu
Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine succinate 6.25 mg
Otc - Purpose
daytime cold & flu
Purpose
Pain reliever/Fever reducer
Cough suppressant
Nasal decongestant
nighttime cold & flu
Purpose
Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Indications & Usage
Uses
temporarily relieves common cold/flu symptoms:
- nasal congestion (Daytime only)
- cough due to minor throat & bronchial irritation
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing (Nithttime only)
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.
Otc - 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.
Otc - 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)
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
- taking the blood thining drug warfarin
Otc - 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)
Otc - 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults and for children even if you do not notice any signs or symptoms.
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
Other information
- store at room temperature
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 dioxide
nighttime 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
Otc - Questions
Questions?call 1-877-290-4008
Package Label.Principal Display Panel
* Please review the disclaimer below.