Label: SEVERE COUGH AND CONGESTION AND COLD AND FLU DAYTIME, NIGHTTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
- NDC Code(s): 41250-591-03, 41250-592-03, 41250-848-95
- Packager: Meijer Distribution Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 3, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet) (Daytime Severe Congestion & Cough)
- Purpose
- Active ingredients (in each caplet) (Nighttime Cold & Flu)
- Purpose
-
Uses (Daytime only)
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
- nasal congestion due to a cold
- the intensity of coughing
- the impulse to cough to help you get to sleep
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
- temporarily relieves:
- Uses (Nighttime only)
-
Warnings
Liver warning (Nighttime only): This product contains acetaminophen. Severe liver damage may occur if you take
- with other drugs containing acetaminophen
- more than 4,000 mg of acetaminophen in 24 hours
- 3 or more alcoholic drinks every day while using this product
Allergy alert (Nighttime only): 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 (Nighttime only): 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 product containing diphenhydramine, even one used on skin (Nighttime only)
- 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.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. (Nighttime only)
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- heart disease
- diabetes
- thyroid disease
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
- liver disease (Nighttime only)
Ask a doctor or pharmacist before use if you are (Nighttime only)
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- marked drowsiness may occur (Nighttime only)
- excitability may occur, especially in children (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
Stop use and ask a doctor if
- nervousness, dizziness, or sleeplessness occur
- symptoms do not get better within 7 days or occur with fever (Daytime only)
- redness or swelling is present (Nighttime only)
- pain, nasal congestion, or cough gets worse or lasts more than 7 days (Nighttime only)
- new symptoms occur (Nighttime only)
- fever gets worse or lasts more than 3 days (Nighttime only)
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients (Daytime only)
-
Inactive ingredients (Nighttime only)
corn starch, croscarmellose sodium, crospovidone, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, iron oxide yellow, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium bicarbonate, stearic acid, talc, titanium dioxide
- Questions or comments?
-
Principal Display Panel
COMBO PACK
30 CAPLETS TOTALNDC 41250-848-95
Meijer®
Maximum Strength
Daytime Severe
Congestion & CoughDextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mgCough Suppressant
Expectorant
Nasal Decongestant• Controls Cough
• Relieves Nasal &
Chest Congestion
• Thins & Loosens Mucus20
Caplets
Actual SizeMaximum Strength
Nighttime Cold & FluAcetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mgPain Reliever/Fever Reducer
Antihistamine/Cough Suppressant
Nasal Decongestant• Relieves Aches,
Fever & Sore Throat
• Relieves Nasal Congestion,
Runny nose & Sneezing
• Controls Cough10
Caplets
Actual Size50844 ORG052364869401
Do Not Take Daytime and
Nighttime Products at the
Same TimeDIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.comPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgTAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF
BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERINGMeijer 44-648694
-
INGREDIENTS AND APPEARANCE
SEVERE COUGH AND CONGESTION AND COLD AND FLU DAYTIME, NIGHTTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:41250-848 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-848-95 1 in 1 CARTON; Type 0: Not a Combination Product 01/03/2024 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 2 BLISTER PACK 20 Part 2 1 BLISTER PACK 10 Part 1 of 2 SEVERE COUGH AND CONGESTION DAYTIME
dextromethorphan hbr, guaifenesin, phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:41250-591 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 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) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FD&C RED NO. 40 (UNII: WZB9127XOA) 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 red (MAROON) Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;648 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-591-03 10 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 01/03/2024 Part 2 of 2 COLD AND FLU NIGHTTIME
acetaminophen. diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:41250-592 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561) FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM) FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) MAGNESIUM STEARATE (UNII: 70097M6I30) METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color blue Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;694 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:41250-592-03 10 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 01/03/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 01/03/2024 Labeler - Meijer Distribution Inc (006959555) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(41250-848) , pack(41250-848, 41250-848) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(41250-848, 41250-848) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(41250-848)