COLD AND FLU DAYTIME, NIGHTTIME SEVERE- acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl
Wal-Mart Stores 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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Equate 44-640677 De-listed
Active ingredients (in each caplet)
(Daytime Severe Cold & Flu)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet)
(Nighttime Severe Cold & Flu)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves common cold and flu symptoms:
- sore throat
- minor aches and pains
- headache
- nasal congestion
- fever
- sinus congestion and pressure
- cough due to minor throat and bronchial irritation
- runny nose and sneezing (Nighttime only)
- sore throat
- 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 (Daytime only)
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:
- skin reddening
- blisters
- rash
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
- high blood pressure
- thyroid disease
- heart disease
- diabetes
- glaucoma (Nighttime only)
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema (Daytime only)
- difficulty in urination due to enlargement of the prostate gland
- a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema (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)
- be careful when driving a motor vehicle or operating machinery (Nighttime only)
- alcohol, sedatives, and tranquilizers may increase drowsiness (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
- 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.
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.
Read each section carefully. Do not take DAYTIME and NIGHTTIME products at the same time.
Directions
- do not take more than directed
- do not take more than 8 caplets of Daytime and Nighttime products in any 24-hour period
- adults and children 12 years and over: take 2 caplets with water every 4 hours
- children under 12 years: ask a doctor
Other information
- TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
- store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
- 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, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Inactive ingredients (Nighttime only)
black iron oxide, corn starch, crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C yellow #6 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, polyvinyl alcohol, povidone, silicon dioxide, sodium starch glycolate, stearic acid, talc, titanium dioxide
Principal Display Panel
COMBO PACK 24 TOTAL CAPLETS INSIDE
Equate™
NDC 49035-641-08
Compare to Vicks® DayQuil® and NyQuil® Severe Cold & Flu Active Ingredients•
| Maximum Strength/Non-Drowsy DayTime Severe
Acetaminophen - Pain Reliever / Fever Reducer Relief of: Actual Size 16 CAPLETS |
Maximum Strength NightTime Severe
Acetaminophen - Pain Reliever / Fever Reducer Relief of: Actual Size 8 CAPLETS |
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
DISTRIBUTED BY: Walmart Inc.,
Bentonville, AR 72716
*This product is not manufactured or distributed by The Procter & Gamble Company, owner of the registered trademark Vicks® DayQuil® Severe Cold & Flu and Vicks® NyQuil® Severe Cold & Flu.
Satisfaction guaranteed-
Or we'll replace it or give you your money back. For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.
50844 REV0519A64067708
44-640677
| COLD AND FLU
DAYTIME, NIGHTTIME SEVERE
acetaminophen, dextromethorphan hbr, doxylamine succinate, guaifenesin, phenylephrine hcl kit |
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| Labeler - Wal-Mart Stores Inc (051957769) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | pack(49035-641) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | pack(49035-641) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(49035-641) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 868734088 | pack(49035-641) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | pack(49035-641) | |