FDA records indicate that there are no current recalls for this drug.
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Night Time Sleep Aid Recall
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Questions & Answers
Side Effects & Adverse Reactions
- with any other product containing diphenhydramine, even one used on the skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products, and other nighttime sleep-aids
- heart disease
- glaucoma
- breathing problem such as occurs with asthma or emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
taking sedatives or tranquilizers or any other sleep-aid.
- drowsiness will occur
- avoid alcoholic drinks and other drugs that cause drowsiness
- be careful when driving a motor vehicle or operating machinery
sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
ask a health professional before use.
Overdose warning: Taking more than directed can cause serious health problems. in case of overdose, get medical help or contact a Poison Control Center right away.
- with any other product containing diphenhydramine, even one used on the skin
- for children under 12 years of age
- with other drugs that cause drowsiness such as antihistamines and nighttime cold/flu products, and other nighttime sleep-aids
- heart disease
- glaucoma
- breathing problem such as occurs with asthma or emphysema or chronic bronchitis
- trouble urinating due to an enlarged prostate gland
taking sedatives or tranquilizers or any other sleep-aid.
Stop use and ask a doctor ifsleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- for the relief of occasional sleeplessness
- reduces time to fall asleep if you have difficulty falling asleep
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Night Time Sleep Aid Manufacturers
- Dolgencorp, Inc. (Dollar General & Rexall)
Night Time Sleep Aid | Dolgencorp, Inc. (dollar General & Rexall)
take only one dose per day (24 hours) - (see overdose warning) mL=milliliter shake well before using measure only with dosing cup provided do not use any other dosing device keep dosing cup with product adults and children 12 years and over one dose=30mL (50 mg) at bedtime if needed, or as directed by a doctor children under 12 years do not use - Harmon Stores
- Hy-vee
- Hyvee Inc
Night Time Sleep Aid | Meijer Distribution Inc
• if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other important information • begin using the gum on your quit day • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 mg according to the following 12 week schedule:Weeks 1 to 6
Weeks 7 to 9
Weeks 10 to 12
1 piece every
1 to 2 hours
1 piece every
2 to 4 hours
1 piece every
4 to 8 hours
• nicotine gum is a medicine and must be used a certain way to get the best results • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns. • repeat this process until most of the tingle is gone (about 30 minutes) • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects. • do not use more than 24 pieces a day • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.
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