SEVERE COLD, COLD AND FLU DAYTIME/NIGHTTIME- acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl
Meijer Distribution 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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Meijer 44-617694-01-Delisted
Active ingredients (in each caplet) (Daytime Severe Cold)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Active ingredients (in each caplet) (Nighttime Cold & Flu)
Acetaminophen 325 mg
Diphenhydramine HCl 12.5 mg
Phenylephrine HCl 5 mg
Uses
- temporarily relieves these common cold and flu symptoms:
- headache
- minor aches and pains
- nasal congestion
- cough
- 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)
- controls cough to help you get to sleep (Nighttime only)
- temporarily reduces fever
Warnings
Liver warning: 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: 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)
- be careful 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
- 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 (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
If taking NIGHTTIME and DAYTIME products, carefully read each section to ensure correct dosing. Do not take DAY & NIGHT at the same time.
Directions
-
do not use 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
COMBO PACK Total 30 Caplets
NDC 41250-694-01
Meijer®
|
Compare to Maximum Daytime
severe
Acetaminophen 325 mg
Pain Reliever/Fever Reducer MAXIMUM STRENGTH •Relieves Aches, Fever & Sore Throat 20 Caplets Actual Size | Compare to Maximum Strength Mucinex® FAST-MAX® NIGHT TIME Cold & Flu active ingredients* Nighttime
Cold &
Acetaminophen 325 mg
Pain Reliever/Fever Reducer MAXIMUM STRENGTH •Relieves Aches, Fever & Sore Throat 10 Caplets Actual Size |
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS
OPENED OR IF BLISTER UNIT IS TORN, BROKEN
OR SHOWS ANY SIGNS OF TAMPERING
*This product is not manufactured or distributed by Reckitt
Benckiser LLC, owner of the registered trademark Maximum
Strength Mucinex® FAST-MAX® Day Time Severe Cold &
Night Time Cold & Flu. 50844 ORG051761769401
DIST. BY MEIJER
DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
www.meijer.com
Meijer 44-617694
| SEVERE COLD, COLD AND FLU
DAYTIME/NIGHTTIME
acetaminophen, dextromethorphan hbr, diphenhydramine hcl, guaifenesin, phenylephrine hcl kit |
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| Labeler - Meijer Distribution Inc (006959555) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 038154464 | pack(41250-694) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867837 | pack(41250-694) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 832867894 | manufacture(41250-694) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 868734088 | pack(41250-694) | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| LNK International, Inc. | 967626305 | pack(41250-694) | |