Label: COLD AND FLU RELIEF SEVERE DAYTIME- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coated
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- NDC Code(s): 11822-0640-8
- Packager: Rite Aid Corporation
- 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 November 1, 2022
If you are a consumer or patient please visit this version.
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- 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 due to minor throat and bronchial irritation
- 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
- 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
- thyroid disease
- diabetes
- heart disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
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
- Questions or comments?
-
Principal Display Panel
11822-0640-8
Compare to the active
ingredients in Vicks®
DayQuil® VapoCOOL®
SEVERE COLD & FLU
+ CONGESTION*
MAXIMUM STRENGTH
SEVERE
COLD & FLU RELIEFDAY
ACETAMINOPHEN
DEXTROMETHORPHAN HBr
GUAIFENESIN • PHENYLEPHRINE HClPAIN RELIEVER / FEVER REDUCER
COUGH SUPPRESSANT • EXPECTORANT • NASAL DECONGESTANT
• Temporarily relieves headache, fever,
sore throat, minor aches & pains, nasal/sinus
congestion & sinus pressure,
cough, chest congestionACTUAL 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® DayQuil® VapoCOOL®
SEVERE COLD & FLU + CONGESTION. 50844 REV0722B64008DISTRIBUTED 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.PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Rite Aid 44-640
-
INGREDIENTS AND APPEARANCE
COLD AND FLU RELIEF SEVERE DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-0640 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 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 STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) 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 orange Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;640 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11822-0640-8 2 in 1 CARTON 11/25/2019 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 final part341 11/25/2019 Labeler - Rite Aid Corporation (014578892) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(11822-0640) , pack(11822-0640) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(11822-0640) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(11822-0640)