Label: SEVERE COLD, COLD AND FLU MAXIMUM STRENGTH, DAYTIME, NIGHTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit
- NDC Code(s): 51316-614-01
- Packager: CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- 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 June 20, 2023
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 Cold)
- Purpose (Daytime Severe Cold)
- Active ingredients (in each caplet) (Nighttime Cold & Flu)
- Purpose (Nighttime Cold & Flu)
-
Uses
- temporarily relieves these common cold and flu symptoms:
- headache
- nasal congestion
- cough
- minor aches and pains
- sore throat
- runny nose and sneezing (Nighttime only)
- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive (Daytime only)
- temporarily reduces fever
- controls cough to help you get to sleep
- temporarily relieves these 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
- with any other product containing diphenhydramine, even one used on skin (Nighttime only)
Ask a doctor before use if you have
- heart disease
- thyroid disease
- diabetes
- liver disease
- high blood pressure
- difficulty in urination due to enlargement of the prostate gland
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- cough that occurs with too much phlegm (mucus)
- a breathing problem such as emphysema or chronic bronchitis (Nighttime only)
- glaucoma (Nighttime only)
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers (Nighttime only)
When using this product
- do not exceed recommended dosage
- excitability may occur, especially in children (Nighttime only)
- marked drowsiness may occur (Nighttime only)
- avoid alcoholic beverages (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (Nighttime only)
- use caution when driving a motor vehicle or operating machinery (Nighttime only)
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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not take DAYTIME and NIGHTTIME products at the same time.
- 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
♥CVS
Health®DAY & NIGHT COMBO PACK
MAXIMUM STRENGTH Daytime
Severe ColdAcetaminophen
Pain reliever/Fever reducer
Dextromethorphan HBr
Cough suppressant
Guaifenesin, Expectorant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Headache + Body Pain
Fever + Sore Throat
Cough + Chest Congestion
Nasal CongestionFor
Ages 12+Actual Size
20 DAYTIME
CAPLETSMAXIMUM STRENGTH Nighttime
Cold & FluAcetaminophen
Pain reliever/Fever reducer
Diphenhydramine HCI
Antihistamine
Cough suppressant
Phenylephrine HCl
Nasal decongestant
MULTI-SYMPTOM
Headache + Body Pain
Fever + Sore Throat
Nasal Congestion
Sneezing & Runny NoseFor
Ages 12+Actual Size
10 NIGHTTIME
CAPLETS30 TOTAL CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGPARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.orgDo not take the
Daytime and Nighttime
caplets at the same time.Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2022 CVS/pharmacy
CVS.com® 1-800-SHOP CVS100% money back
guaranteed.
CVS.com/returnpolicy50844 ORG102161769401
CVS 44-617694
-
INGREDIENTS AND APPEARANCE
SEVERE COLD, COLD AND FLU MAXIMUM STRENGTH, DAYTIME, NIGHTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-614 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-614-01 1 in 1 CARTON; Type 0: Not a Combination Product 08/16/2022 02/22/2025 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 COLD MAXIMUM STRENGTH, DAYTIME
acetaminophen, dextromethorphan hbr, guaifenesin phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:51316-917 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) 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 Score no score Shape OVAL Size 19mm Flavor Imprint Code 44;617 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 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 final part341 08/16/2022 Part 2 of 2 COLD AND FLU MAXIMUM STRENGTH, NIGHTTIME
acetaminophen, diphenhydramine hcl, phenylephrine hcl tablet, film coatedProduct Information Item Code (Source) NDC:51316-699 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 (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 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 final part341 08/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/16/2022 02/22/2025 Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867837 manufacture(51316-614) , pack(51316-614) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 832867894 manufacture(51316-614) Establishment Name Address ID/FEI Business Operations LNK International, Inc. 117025878 manufacture(51316-614)