SPL MEDGUIDE

Acetaminophen, Caffeine  and Dihydrocodeine Bitartrate Tablets, CIII
Acetaminophen (a seet” a min’ oh fen), Caffeine (ka feen’) and Dihydrocodeine Bitartrate (dye hye” droe koe’ deen bye tar’ trate)

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets are:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage moderate to moderately severe pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets:

• Get emergency help right away if you take too much Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets (overdose). When you first start taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking  Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets with other opioid medicines, Benzodiazepines, Alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma and death.
• Never give anyone else your Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets. They could die from taking it. Store Acetaminophen, Caffeine and  Dihydrocodeine Bitartrate Tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets is against the law.

Important Information Guiding  Use in Pediatric Patients:

• Do not give Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets to a child younger than 12 years of age.
• Do not give Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets to a child younger than  18 years of age after surgery to  remove the tonsils and/or    adenoids.
• Avoid giving Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets to  children between  12 to 18 years of age who have risk factors for breathing problems such as obstructive sleep apnea, obesity, or underlying lung problems.

Do not take Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets if you have:

• severe asthma, trouble breathing, or other lung   problems.
• a bowel blockage or have narrowing of the stomach or intestines.
• previously had an allergic reaction to  dihydrocodeine or  acetaminophen.

Before taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, tell your healthcare provider if you have a history  of:

• head injury, seizures
• liver, kidney, thyroid problems
• problems urinating
• pancreas or gallbladder problems
• abuse of street or prescription drugs, alcohol addiction, or mental  health problems. 
• having been told by your healthcare provider that you are a “rapid metabolizer” of certain medicines.

Tell your healthcare provider if you are:

• pregnant or planning to become pregnant. Prolonged use of Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended; may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets with certain other medicines can cause serious side effects that could lead to death.

When taking  Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets:

• Do not change your dose. Take Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose of 2 Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets orally every 4 hours, as needed. Do not take more than your prescribed dose. If you miss a dose, take  your next dose at your usual time.
• Call your healthcare provider if the dose you are taking  does not control your   pain.
• If you have been taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets regularly, do not stop taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets without talking to your healthcare provider.
• After you stop taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets, dispose the unused Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets in accordance with local state  guidelines and/or regulations.

While taking Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets DO NOT:

• Drive or operate heavy machinery, until you know how Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets affect you. Acetaminophen, Caffeine and Dihydrocodeine Bitartrate  Tablets can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets may cause you to overdose and die.

The possible side effects of Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov

Distributed by: Atland Pharmaceuticals, LLC.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: April 2017

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets 3 0 Count Bottle

NDC 71993-300-30

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets CIII

Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablets 325 mg/30 mg/16 mg)
Rx ONLY
30 TABLETS

DESCRIPTION
Each tablet contains:
Acetaminophen .................... 325 mg
Caffeine ................................ 30  mg

Dihydrocodeine bitartrate..........16 mg

USUAL DOSAGE: See package insert for full prescribing information.

WARNING: Keep this and all medications out of the reach of children.

PHARMACIST: Dispense in a tight, light-resistant container with a child-resistant closure. Store at 20° to  25°C (68° to  77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Distributed by:
Atland Pharmaceuticals Sylacauga, AL 35150

ATL.300.98
Rev: 01/2020