DAYTIME & NIGHTTIME RELIEF VALUE PACK
Drug Labeling and Warnings
Drug Details [pdf]
DAYTIME SEVERE COLD AND COUGH NIGHTTIME SEVERE COLD AND COUGH- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl
CVS Pharmacy,Inc.
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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DAYTIME & NIGHTTIME RELIEF VALUE PACK
Active ingredients (in each packet) – Daytime Severe Cold and Cough
Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Phenylephrine HCl 10 mg
Active ingredients (in each packet) - Nighttime Severe Cold and Cough
Acetaminophen 650 mg
Diphenhydramine HCl 25 mg
Phenylephrine HCl 10 mg
Purposes - Daytime Severe Cold and Cough
Pain reliever/fever reducer
Cough Suppressant
Nasal Decongestant
Purpose - Nighttime Severe Cold and Cough
Pain reliever/fever reducer
Antihistamine/cough suppressant
Nasal Decongestant
Uses - Daytime Severe Cold and Cough
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Uses - Nighttime Severe Cold and Cough
- temporarily relieves these symptoms due to a cold:
- minor aches and pains
- minor sore throat pain
- headache
- nasal and sinus congestion
- runny nose
- sneezing
- itchy nose or throat
- itchy, watery eyes due to hay fever
- cough due to minor throat and bronchial irritation
- temporarily reduces fever
Warnings – Daytime Severe Cold and Cough and Nighttime Severe Cold and Cough
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:
- ●Skin reddening● blisters● rash
- Is 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 - Daytime Severe Cold and Cough
- in a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a 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.
Do not use - Nighttime Severe Cold and Cough
- in a child under 12 years of age
- if you are allergic to acetaminophen
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or a pharmacist.
- with any other product containing diphenhydramine, even one used on skin
- 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 a MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have - Daytime Severe Cold and Cough
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor before use if you have - Nighttime Severe Cold and Cough
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are - Daytime Severe Cold and Cough
taking the blood thinning drug warfarin
Ask a doctor or pharmacist before use if you are - Nighttime Severe Cold and Cough
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product - Nighttime Severe Cold and Cough
- do not exceed recommended dosage
- avoid alcoholic drinks
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if – Daytime Severe Cold and Cough /Nighttime Severe Cold and Cough
- nervousness, dizziness, or sleeplessness occurs
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- pain, cough or nasal congestion gets worse or lasts more than 7 days
- 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions – Daytime Severe Cold and Cough
- do not use more than directed
- take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor
- adults and children 12 years of age and over: one packet
- children under 12 years of age: do not use
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat
Directions Nighttime Severe Cold and Cough
- do not use more than directed
- take every 4 hours, while symptoms persist, Do not take more than 5 packets in 24 hours unless directed by a doctor.
- adults and children 12 years of age and over: one packet
- children under 12 years of age: do not use
- dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes.
- if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat
Other information - Daytime Severe Cold and Cough
- each packet contains: potassium 6 mg
- store at room temperature. Protect from excessive heat and moisture
- see carton for full labeling.
Other information - Nighttime Severe Cold and Cough
- each packet contains: potassium 6 mg
- store at controlled room temperature 20°-25oC (68°-77oF). Protect from excessive heat and moisture
Inactive ingredients - Daytime Severe Cold and Cough
Blue#1, citric acid, flavors, maltodextrin, potassium chloride, red 40#, silica, sucralose, sucrose
Inactive ingredients - Nighttime Severe Cold and Cough
citric acid, flavors, maltodextrin, potassium chloride, silica ,sucralose, sucrose, yellow #6
Package/Label Principal Display Panel
DAYTIME 6 PACKETS + NIGHTTIME 6 PACKETS = 12 PACKETS TOTAL
Compare to active ingredients in Theraflu® Daytime Severe Cold and Cough and Nighttime Severe Cold & Cough*
Daytime
Severe Cold and Cough
ACETAMINOPHEN - Pain Reliever/ Fever Reducer
DEXTROMETHORPHAN HBr – Cough Suppressant
PHENYLEPHRINE HCl – Nasal Decongestant
Relieves:
Nasal congestion
Sore throat pain
Cough
Headache
Body ache
Fever
BERRY FLAVOR
Infused with Menthol and Green Tea Flavors
6 PACKETS
NIGHTTIME
Severe Cold and Cough
ACETAMINOPHEN - Pain Reliever/ Fever Reducer
DIPHENHYDRAMINE HCl – Antihistamine/ Cough Suppressant
PHENYLEPHRINE HCl – Nasal Decongestant
Relieves:
Nasal congestion
Sore throat pain
Cough
Headache
Body ache
Fever
Runny nose
Sneezing
Honey Lemon Flavor Infused with Chamomile &White Tea Flavors
6 PACKETS
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READ ALL WARNINGS AND DIRECTIONS ON CARTON BEFORE USE .KEEP CARTON FOR REFERENCE, DO NOT DISCARD. |
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DO NOT TAKE BOTH PRODUCTS AT THE SAME TIME OR TAKE MORE THAN 5 DOSES IN TOTAL IN ANY 24 –HOUR PERIOD. |
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DO NOT TAKE A DOSE OF THE NIGHTTIME PRODUCT SOONER THAN 4 HOURS AFTER THE LAST DOSE OF DAYTIME PRODUCT UNLESS DIRECTED BY DOCTOR. |
*These Products are not manufactured or distributed by GSK Consumer Healthcare, distributor of Theraflu Daytime Severe Cold & Cough and Theraflu nighttime severe Cold & Cough
Distributed by: CVS Pharmacy, Inc.
One CVS Drive ,Woonsocket, RI 02895
©2016 CVS/Pharmacy
CVS.com® 1-800-SHOP CVS
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Tamper Evident Inner Unit Do not use if sealed packet is Torn or Broken |
| DAYTIME SEVERE COLD AND COUGH NIGHTTIME SEVERE COLD AND COUGH
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, phenylephrine hcl kit |
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| Labeler - CVS Pharmacy,Inc. (062312574) |
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