NDC 11822-0895 Severe Cold And Flu Relief
Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl Powder, For Solution Oral
Product Information
What is NDC 11822-0895?
The NDC code 11822-0895 is assigned by the FDA to the product Severe Cold And Flu Relief which is a human over the counter drug product labeled by Rite Aid Corporation. The generic name of Severe Cold And Flu Relief is acetaminophen, dextromethorphan hbr, phenylephrine hcl. The product's dosage form is powder, for solution and is administered via oral form. The product is distributed in a single package with assigned NDC code 11822-0895-0 6 powder, for solution in 1 carton . 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 Severe Cold And Flu Relief?
This product is used as Pain reliever/fever reducerCough suppressantNasal decongestant. •temporarily relieves these symptoms due to a cold:•minor aches and pains•minor sore throat pain•headache•nasal and sinus congestion•cough due to minor throat and bronchial irritation•temporarily reduces fever
Product Characteristics
Flavor(s) | HONEY (C73394 - GREEN TEA) LEMON (C73396 - GREEN TEA) |
Product Details
What are Severe Cold And Flu Relief Active Ingredients?
- ACETAMINOPHEN 500 mg/1 - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
- DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.
- PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 - An alpha-1 adrenergic agonist used as a mydriatic, nasal decongestant, and cardiotonic agent.
Severe Cold And Flu Relief Active Ingredients UNII Codes
- 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: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral Solution
- RxCUI: 1189316 - acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral Solution
- RxCUI: 1189316 - APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral Solution
Severe Cold And Flu Relief Inactive Ingredients UNII Codes
- ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
- ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
- ASPARTAME (UNII: Z0H242BBR1)
- SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
- D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
- FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
- FD&C RED NO. 40 (UNII: WZB9127XOA)
- MALTODEXTRIN (UNII: 7CVR7L4A2D)
- SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
- SUCROSE (UNII: C151H8M554)
- TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)
Pharmacologic Class(es)
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
* Please review the disclaimer below.
Severe Cold And Flu Relief 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
- ACTIVE INGREDIENTS (IN EACH PACKET)
- PURPOSES
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Active Ingredients (In Each Packet)
Acetaminophen 500 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Purposes
Pain reliever/fever reducer
Cough suppressant
Nasal decongestant
Uses
• temporarily relieves these symptoms due to a cold:• minor aches and pains• minor sore throat pain• headache• nasal and sinus congestion• cough due to minor throat and bronchial irritation• temporarily reduces fever
Warnings
Liver warning: This product contains 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• skin reddening• blisters• rash
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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
• in a child under 12 years of age• if you have ever had an allergic reaction to this product or any of its ingredients• 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
• liver disease• heart disease• high blood pressure• thyroid disease• diabetes• trouble urinating due to an enlarged prostate gland• cough that occurs with too much phlegm (mucus)• cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema• a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
taking the blood thinning drug warfarin
When Using This Product
do not exceed recommended dosage
Stop Use And Ask A Doctor If
• nervousness, dizziness, or sleeplessness occurs• fever gets worse or lasts more than 3 days• redness or swelling is present• new symptoms occur• pain, cough or nasal congestion gets worse or lasts more than 7 days• cough comes back or occurs with rash or headache that lasts. These could be signs of serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Keep Out Of Reach Of Children.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• do not use more than directed (see overdose warning)• take every 4 hours, while symptoms persist. Do not take more than 6 packets in 24 hours unless directed by a doctor.• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.• if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.
Age | Dose |
adults and children 12 years of age and over | one packet |
children under 12 years of age | do not use |
Other Information
• each packet contains: potassium 10 mg and sodium 25 mg• phenylketonurics: contains phenylalanine 22 mg per packet• store at 20-25°C (68-77°F). Protect product from heat and moisture.
Inactive Ingredients
acesulfame potassium, anhydrous citric acid, aspartame, colloidal silicon dioxide, D&C yellow #10, FD&C blue #1, FD&C red #40, flavors, maltodextrin, pregelatinized starch, sodium citrate, sucrose, tribasic calcium phosphate
Questions Or Comments?
1-800-719-9260
Package/Label Principal Display Panel
Compare to the active ingredients of Theraflu® Multi-Symptom Severe Cold
SEVERE COLD & FLU RELIEF
DAYTIME
ACETAMINOPHEN 500 mg
DEXTROMETHORPHAN HBr 20 mg
PHENYLEPHRINE HCl 10 mg
PAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT
NASAL DECONGESTANT
Relieves:
headache & fever
nasal & sinus congestion
sore throat pain
body ache
cough
GREEN TEA & HONEY LEMON FLAVORS
6 PACKETS
* Please review the disclaimer below.