Label: SEVERE NIGHTTIME COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coated
- NDC Code(s): 11822-0677-8
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 18, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet)
- Purpose
-
Uses
- temporarily relieves common cold and flu symptoms:
- minor aches and pains
- sinus congestion and pressure
- sore throat
- fever
- headache
- nasal congestion
- cough to help you sleep
- runny nose and sneezing
- cough due to minor throat and bronchial irritation
- reduces swelling of nasal passages
- promotes nasal and/or sinus drainage
- temporarily restores freer breathing through the nose
- temporarily relieves common cold and flu symptoms:
-
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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- blisters
- rash
- skin reddening
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
- 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.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- diabetes
- thyroid disease
- heart disease
- glaucoma
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product
-
do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic beverages
- be careful when driving a motor vehicle or operating machinery
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- 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.
- more than 4,000 mg of acetaminophen in 24 hours
- Directions
- Other information
-
Inactive ingredients
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
- Questions or comments?
-
Principal display panel
NDC 11822-0677-8
Compare to the active ingredients in
Vicks® NyQuil® VapoCOOL®
SEVERE COLD & FLU + CONGESTION*MAXIMUM STRENGTH
SEVERE NIGHTTIME
COLD & FLU RELIEFACETAMINOPHEN
DEXTROMETHORPHAN HBr
DOXYLAMINE SUCCINATE • PHENYLEPHRINE HClPAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT • ANTIHISTAMINE • NASAL DECONGESTANTRelieves headache, fever, sore throat,
minor aches & pains, nasal/sinus congestion
& sinus pressure, sneezing, runny nose, coughActual Size
24 CAPLETS
TAMPER EVIDENT: DO NOT USE IF
PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING*This product is not
manufactured or distributed
by The Procter & Gamble
Company, owner of the
registered trademark
Vicks® NyQuil® VapoCOOL®
SEVERE COLD & FLU +
CONGESTION.
50844
REV0722B67708DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE,
CAMP HILL, PA 17011
www.riteaid.comSATISFACTION
GUARANTEE
If you're not satisfied,
we'll happily refund your money.
Rite Aid 44-677
-
INGREDIENTS AND APPEARANCE
SEVERE NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0677 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 FERROSOFERRIC OXIDE (UNII: XM0M87F357) STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) D&C YELLOW NO. 10 ALUMINUM LAKE (UNII: CQ3XH3DET6) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color green Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;677 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0677-8 2 in 1 CARTON 12/10/2019 1 12 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 12/10/2019 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-0677) , pack(11822-0677) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(11822-0677) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 868734088 manufacture(11822-0677) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-0677)