Severe Cold, Cold and Flu by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED / LNK International, Inc. CVS 44-617694-Delisted
Severe Cold, Cold and Flu by
Drug Labeling and Warnings
Severe Cold, Cold and Flu by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED, LNK International, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
SEVERE COLD, COLD AND FLU MAXIMUM STRENGTH, DAYTIME, NIGHTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl
CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
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.
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CVS 44-617694-Delisted
Active ingredients (in each caplet) (Daytime Severe Cold)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Purpose (Daytime Severe Cold)
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Active ingredients (in each caplet) (Nighttime Cold & Flu)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Purpose (Nighttime Cold & Flu)
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal decongestant
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
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
-
do not take more than directed
- do not take more than 12 caplets in any 24-hour period
- adults and children 12 years and over: take 2 caplets every 4 hours
- children under 12 years: do not use
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
- see end flap for expiration date and lot number
Inactive ingredients (Daytime only)
corn starch, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
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
Principal display panel
♥CVS
Health®
DAY & NIGHT COMBO PACK
| MAXIMUM STRENGTH
Daytime
Acetaminophen MULTI-SYMPTOM For Actual Size
20 DAYTIME | MAXIMUM STRENGTH
Nighttime
Acetaminophen MULTI-SYMPTOM For Actual Size
10 NIGHTTIME |
30 TOTAL CAPLETS
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Do 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 CVS
100% money back
guaranteed.
CVS.com/returnpolicy
50844 ORG102161769401
CVS 44-617694
| SEVERE COLD, COLD AND FLU
MAXIMUM STRENGTH, DAYTIME, NIGHTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit |
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| 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) | |
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